Method and apparatus for mitral valve chord repair

ABSTRACT

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, the catheter can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims priority to U.S. Provisional Application No.63/040,389, filed Jun. 17, 2020, the entirety of this application ishereby incorporated by reference herein for all purposes.

Any and all applications for which a foreign or domestic priority claimis identified in the PCT Request as filed with the present applicationare hereby incorporated by reference.

BACKGROUND

The present disclosure relates to mitral valve repair or replacement andmore generally to methods and methods and devices for mitral valvereshaping, repair and/or replacement of mitral chords to restore properfunctioning of the mitral valve from a state of mitral valveregurgitation.

The heart includes four heart valves, which allow blood to pass throughthe four chambers of the heart in one direction. The four valves are thetricuspid, mitral, pulmonary and aortic valves. The four chambers arethe right and left atria (upper chambers) and right and left ventricle(lower chambers).

The mitral valve is formed by two leaflets, which are known as theanterior leaflet and the posterior leaflet, which open and close inresponse to pressure placed on the leaflets by the pumping of the heart.There are several problems that can develop or occur with respect to themitral valve. Such problems include mitral valve regurgitation (MR), inwhich the mitral valve leaflets do not close properly, which can causeleakage of the mitral valve. Severe mitral regurgitation can adverselyaffect cardiac function and compromise a patient's quality of life andlife-span.

Several techniques have been developed for correcting mitral valveregurgitation. These include heart transplant, valve replacement orrepair, chordae tendinea shortening or replacement and mitral annularrepair also known as annuloplasty, depending upon the stage andunderlying etiology.

As it relates to chordae tendinea replacement or repair, certainsurgical and trans apical approaches have been proposed. Despite thoseefforts, however, there remains a need for a transvascular approach forchordae tendinea replacement or repair, for, such as but not limited to,reduce or eliminate MR.

SUMMARY

Methods and devices for transvascular prosthetic chordae tendineaimplantation are disclosed. A catheter is advanced into the left atrium.From an atrium side, the catheter can be anchored to a superior surfaceof a mitral valve leaflet and a leaflet anchor can be advanced into themitral valve leaflet to secure the mitral valve leaflet to a leafletsuture. A ventricular anchor is anchored to the wall of the ventricle tosecure the ventricular wall to a ventricle suture. The leaflet sutureand the ventricle suture may be tensioned and connected by a suture lockto form an artificial chordae.

According to one example (“Example 1”), a tissue anchor includes a hub,a suture extending proximally from the hub, a helical anchor extendingdistally from the hub; and a secondary anchor axially moveable in adistal direction from a first configuration to a second, deployedconfiguration to engage tissue and inhibit unscrewing of the helicalanchor.

According to another example (“Example 2”) further to Example 1, thesecondary anchor comprises a tine that extends between a proximal endand a sharpened distal end.

According to another example (“Example 3”) further to Example 2, thetine is carried by a support.

According to another example (“Example 4”) further to Example 3, thesupport includes an annular structure.

According to another example (“Example 5”) further to any one ofExamples 3 or 4, the support can receive a tubular structure of adeployment system for advancing the support distally with respect to thehelical anchor.

According to another example (“Example 6”) further to Example 2, the hubincludes a tine guide for axially moveably receiving the tine.

According to another example (“Example 7”) further to Example 6, thetine guide includes a deflection surface for deflecting the tine into alaunch angle that inclines radially outwardly in the distal direction.

According to another example (“Example 8”) further to Example 7, thelaunch angle is within a range of 30 to 45 degrees.

According to another example (“Example 9”) further to Example 1, the hubincludes an aperture for axially moveably receiving the secondaryanchor.

According to another example (“Example 10”) further to any one ofExamples 1-9, the tissue anchor further includes a core wire attached tothe hub and extending concentrically through the helical anchor.

According to another example (“Example 11”) further to any one ofExamples 1-10, the tissue anchor further includes a suture anchor guideextending proximally from the hub.

According to another example (“Example 12”) further to Example 11, in asecond, deployed configuration, the secondary anchor extends through thesuture anchor guide.

According to another example (“Example 13”) further to Example 12, thesecondary anchor extends through an aperture in the suture anchor guide.

According to another example (“Example 14”) further to Example 13, asthe secondary anchor moves to the second, deployed configuration, thesecondary anchor is operable to pierce the suture anchor guide.

According to another example (“Example 15”) further to Example 1, thetissue anchor further includes a radiopaque marker carried by thesecondary anchor.

According to another example (“Example 16”) further to any one ofExamples 1-15, the tissue anchor further includes a core wire attachedto the hub and extending concentrically through the helical anchor.

According to another example (“Example 17”) further to Example 16, thetissue anchor further includes a radiopaque marker axially movablycarried by the core wire.

According to another example (“Example 18”) further to Example 16, thetissue anchor further includes a spring carried by the core wire.

According to another example (“Example 19”) further to Example 16, thecore wire extends distally beyond the helical anchor.

According to another example (“Example 20”) further to Example 16, thetissue anchor further includes a distal stop on the core wire operableto limit distal travel of the radiopaque marker.

According to another example (“Example 21”) further to Example 1, thetissue anchor further includes a tissue piercing point on a distal endof the helical anchor, and a barb on the helical anchor, proximal to thepoint and configured to resist rotation of the helical anchor out ofengagement with tissue.

According to another example (“Example 22”) further to any one ofExamples 1-21, the secondary anchor is operable to increase an anchortorque resistance of the tissue anchor by a factor between 2 to 5 ascompared to an anchor torque resistance of the tissue anchor without thesecondary anchor.

According to another example (“Example 23”) further to any one ofExamples 1-21, an anchor torque resistance of the helical anchor withthe secondary anchor is between 2 N/cm to 5 N/cm.

According to another example (“Example 24”) further to any one ofExamples 1-21, the secondary anchor increases an anchor torqueresistance of the helical anchor by at least a factor of 2 as comparedto an anchor torque resistance of the tissue anchor without thesecondary anchor.

According to another example (“Example 25”) further to any one ofExamples 1-21, an anchor torque resistance of the helical anchor isgreater than 2 N/cm.

According to one example (“Example 26”), a method of transvascularprosthetic chordae tendinae implantation includes advancing a catheterinto a left atrium, through a mitral valve, and into a left ventricle;deploying a ventricular anchor from the catheter and into a wall of theleft ventricle by rotating a helical tissue anchor into the wall of theleft ventricle; deploying a secondary tissue anchor into the wall of theleft ventricle to inhibit unscrewing of the helical tissue anchor;leaving a ventricular suture attached to the ventricular anchor andextending proximally through the catheter; from an atrium side, securinga leaflet anchor catheter to a mitral valve leaflet; with the leafletanchor catheter secured to the leaflet, advancing a leaflet anchor fromthe catheter through the mitral valve leaflet to secure the mitral valveleaflet to a leaflet suture, with the leaflet suture extendingproximally through the catheter; and securing the leaflet suture to theventricular suture to limit a range of travel of the leaflet in adirection of the left atrium.

According to another example (“Example 27”) further to Example 26, inwhich deploying the secondary tissue anchor comprises axially advancingthe secondary tissue anchor in a distal direction with respect to thehelical tissue anchor.

According to another example (“Example 28”) further to Example 26, inwhich deploying the secondary tissue anchor increases an anchor torqueresistance of the ventricular anchor by a factor of between 2 to 5 ascompared to an anchor torque resistance of the ventricular anchorwithout the secondary anchor.

According to another example (“Example 29”) further to Example 26, ananchor torque resistance of the tissue anchor and secondary tissueanchor is between 2 N/cm to 5 N/cm.

According to another example (“Example 30”) further to Example 26, thesecondary tissue anchor increases an anchor torque resistance of theventricular anchor by at least a factor of 2 as compared to an anchortorque resistance of the ventricular anchor without the secondaryanchor.

According to another example (“Example 31”) further to Example 26, ananchor torque resistance of the secondary tissue anchor and theventricular anchor is at least greater than 2 N/cm.

According to one example (“Example 32”), an access system for directinga ventricular anchor sheath at a target site in a left ventricleincludes a delivery catheter having an elongate, flexible tubular bodywith a proximal end, a distal end, a central axis and a steering zonenear the distal end, the steering zone actively deflectable to provide adelivery catheter curve residing in a delivery catheter curve plane; andan anchor sheath axially advanceable through the delivery catheter, theanchor sheath having a proximal preset curve residing in a proximalpreset curve plane and a distal preset curve, wherein the anchor sheathis configured to rotate within the delivery catheter to bias theproximal preset curve plane into alignment with the delivery cathetercurve plane in response to axial alignment of the proximal preset curvewithin the delivery catheter curve.

According to another example (“Example 33”) further to Example 32, thedistal preset curve resides in a distal preset curve plane which isangled from the proximal preset curve plane.

According to another example (“Example 34”) further to any one ofExamples 32-33, in which the delivery catheter curve is activelyadjustable throughout a range of at least 10 to 150 degrees.

According to one example (“Example 35”), an access system for directinga ventricular anchor sheath at a target site in a left ventricleincludes a delivery catheter having an elongate, flexible tubular bodywith a proximal end, a distal end and a steering zone near the distalend, the steering zone actively deflectable to provide a deliverycatheter curve residing in a delivery catheter curve plane; and ananchor sheath axially advanceable through the delivery catheter, theanchor sheath having a proximal preset curve residing in a proximalpreset curve plane and a distal preset curve, wherein the proximalpreset curve and the delivery catheter curve are configured to cooperateto provide tactile indicium of a rotational alignment of the anchorsheath within the delivery catheter.

According to one example (“Example 36”), a ventricular anchor deliverysheath includes an elongate, flexible tubular body having a proximalend, a distal end, and a longitudinal axis; a proximal preset curve inthe tubular body; and a distal preset curve in the tubular body

According to another example (“Example 37”) further to Example 36, theproximal preset curve resides in a first plane and the distal presetcurve resides in a second plane, and the second plane is rotationallyangled from the first plane.

According to another example (“Example 38”) further to Example 37, thesecond plane is rotationally angled from the first plane by an anglewithin a range from 40 to 75 degrees.

According to another example (“Example 39”) further to any one ofExamples 37-38, the distal preset curve has an angle within a range offrom 5 to 60 degrees in the first plane.

According to another example (“Example 40”) further to any one ofExamples 36-39, a length of the distal preset curve is no more than 50%of a length of the proximal preset curve.

According to another example (“Example 41”) further to any one ofExamples 36-39, a length of the distal preset curve is no more than 20%of a length of the proximal preset curve.

According to another example (“Example 42”) further to any one ofExamples 36-41, a distance between a longitudinal center of the proximalpreset curve and a longitudinal center of the distal preset curve iswith a range between 45 and 85 millimeters.

According to another example (“Example 43”) further to any one ofExamples 36-41, a longitudinal center of distal preset curve is within arange of from 50 to 70 millimeters from the distal end of theventricular anchor delivery sheath.

According to another example (“Example 44”) further to any one ofExamples 36-41, a longitudinal center of proximal preset curve is withina range of from 100 to 145 millimeters from the distal end of theventricular anchor delivery sheath.

According to another example (“Example 45”) further to any one ofExamples 36-44, a distal anchor compartment having a collapsible sidewall.

According to another example (“Example 46”), a ventricular anchordelivery sheath includes an elongate, flexible tubular body having aproximal end, a distal end, and a longitudinal axis; and a distal presetcurve in the tubular body.

According to another example (“Example 47”) further to Example 46, alongitudinal center of distal preset curve is within a range of from 50to 70 millimeters from the distal end of the ventricular anchor deliverysheath.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting on scope.

FIG. 1 illustrates placement of a ventricular anchor via transceptalapproach to the mitral valve, in accordance with an embodiment.

FIGS. 2A and 2B illustrate a ventricular anchor, in accordance with anembodiment.

FIG. 2C is a perspective view of a ventricular anchor on the distal endof a ventricular anchor deployment tool, in accordance with anembodiment.

FIG. 2D is a perspective view of the proximal end of a ventricularanchor deployment tool, in accordance with an embodiment.

FIG. 2E is a partially exploded perspective view of a ventricular anchorand the distal end of a ventricular anchor deployment tool, inaccordance with an embodiment.

FIG. 2F illustrates a ventricular anchor with a secondary anchor in afirst configuration, in accordance with an embodiment.

FIG. 2G illustrates the ventricular anchor of FIG. 2F with the secondaryanchor in a second, deployed configuration, in accordance with anembodiment.

FIG. 3 illustrates the deployment end of a catheter positioned to engagea leaflet of the mitral valve, in accordance with an embodiment.

FIG. 4 illustrates the leaflet captured by the helical leaflet anchor,and a needle crossing through the leaflet from the atrium to theventricle, in accordance with an embodiment.

FIG. 5 illustrates a pledget type leaflet anchor deployed from theneedle and into the ventricle, in accordance with an embodiment.

FIG. 6A illustrates proximal traction on a leaflet suture to collapsethe pledget against the ventricular side of the leaflet, in accordancewith an embodiment.

FIGS. 6B-6D illustrate details of a pledget type leaflet anchor, inaccordance with an embodiment.

FIG. 7 illustrates a deployed leaflet anchor and suture and a deployedventricular anchor and suture ready for tensioning and attachment of asuture lock, in accordance with an embodiment.

FIG. 8 illustrates a perspective view of a distal end of the leafletanchor delivery subsystem, in accordance with an embodiment.

FIG. 9 illustrates a perspective view of a proximal end of the leafletanchor delivery subsystem, in accordance with an embodiment.

FIG. 10 illustrates an exploded view of the distal end of the leafletanchor delivery subsystem, in accordance with an embodiment.

FIG. 11 depicts advancing a suture lock via a suture lock deliverysubsystem over the leaflet anchor suture and ventricular anchor sutureto connect the leaflet anchor to the ventricular anchor, in accordancewith an embodiment.

FIG. 12 depicts the suture lock in a locked position after the tensionhas been adjusted and the suture tails having been severed, inaccordance with an embodiment.

FIG. 13 depicts a perspective view of a distal end of the suture lockdelivery subsystem, in accordance with an embodiment.

FIG. 14 depicts a perspective view of a proximal end of the suture lockdelivery subsystem, in accordance with an embodiment.

FIG. 15 depicts a partially exploded view of the distal end of thesuture lock delivery subsystem, in accordance with an embodiment.

FIG. 16 depicts a perspective view of a distal end of a suture cuttingassembly, in accordance with an embodiment.

FIG. 17 depicts a side view of a cutting assembly portion of the suturelock delivery subsystem in a configuration where the cutting head is notyet advanced for holding the sutures prior to being severed, inaccordance with an embodiment.

FIG. 18 depicts a side view of the cutting assembly portion of thesuture lock delivery subsystem in a configuration where the cutting headhas been advanced for severing the sutures, in accordance with anembodiment.

FIG. 19 depicts a side view of a suture lock and a distal end of atorque driver configured to engage the suture lock, in accordance withan embodiment.

FIG. 20 depicts a proximal end view of a suture lock, in accordance withan embodiment.

FIG. 21 depicts a distal end of view of a suture lock, in accordancewith an embodiment.

FIG. 22A is a side view of a ventricular anchor delivery subsystemaccording to aspects of the disclosure, in accordance with anembodiment.

FIG. 22B is a side view of a proximal portion of the ventricular anchordelivery subsystem shown in FIG. 22A, in accordance with an embodiment.

FIG. 22C is a side view of an intermediate portion of the ventricularanchor delivery subsystem shown in FIG. 22A, in accordance with anembodiment.

FIG. 22D is a side view of a distal portion of the ventricular anchordelivery subsystem shown in FIG. 22A, in accordance with an embodiment.

FIG. 22E is a longitudinal cross-sectional view taken through a portionof FIG. 22D, in accordance with an embodiment.

FIG. 22F is longitudinal cross-sectional view taken through a mandrelthat can be used to form the distal portion of the ventricular anchordelivery subsystem shown in FIG. 22A, in accordance with an embodiment.

FIG. 22G is a side view of an embodiment of a distal end of deliverycatheter articulated into a first bend, in accordance with anembodiment.

FIG. 22H is a perspective view of an embodiment of a ventricular anchorsheath preset with a first bend and a second bend, in accordance with anembodiment.

FIG. 22I is a top view of the ventricular anchor sheath of FIG. 22H, inaccordance with an embodiment.

FIG. 22J is a side view of the ventricular anchor sheath of FIGS. 22H-I,in accordance with an embodiment.

FIG. 22K is a front view of the ventricular anchor sheath of FIGS.22H-J, in accordance with an embodiment.

FIG. 22L illustrates placement of a ventricular anchor with theventricular anchor sheath of FIGS. 22H-K and delivery catheter of FIG.22G, in accordance with an embodiment.

FIG. 23A is a top view of an embodiment of a cutter catheter accordingto aspects of the disclosure, in accordance with an embodiment.

FIG. 23B is a side and partial cross-sectional view of the cuttercatheter of FIG. 23A, in accordance with an embodiment.

FIG. 23C is a cross-sectional view taken along line 23C-23C of FIG. 23A,in accordance with an embodiment.

FIG. 24A is a front view of a cutter housing of the cutter catheter ofFIG. 23A according to aspects of the disclosure, in accordance with anembodiment.

FIG. 24B is a side view of the cutter housing of FIG. 23A, in accordancewith an embodiment.

FIG. 24C is a cross-sectional side view of the cutter housing of FIG.23B, in accordance with an embodiment.

FIG. 24D is a view of the cutter housing taken from line 24D-24D of FIG.24C, in accordance with an embodiment.

FIG. 25A is front view of an embodiment of a cutter head, in accordancewith an embodiment.

FIG. 25B is a side view of the cutter head of FIG. 25A, in accordancewith an embodiment.

FIG. 26 is perspective side view of the cutter head positioned with thecutter housing with the cutter housing shown in phantom, in accordancewith an embodiment.

FIG. 27 is a cross-sectional side view of a handle of an embodiment ofthe cutter catheter, in accordance with an embodiment.

FIG. 28 is a top view of an embodiment of a suture and pledget that canform an embodiment of a leaflet anchor, in accordance with anembodiment.

FIG. 29 is a cross-sectional view taken through line B-B of FIG. 28 , inaccordance with an embodiment.

FIG. 30 is a top view of an embodiment of a suture and pledget withapertures that can form an embodiment of a leaflet anchor, in accordancewith an embodiment.

FIG. 31 illustrates an embodiment of the leaflet anchor of FIG. 30 withthe suture extending through the apertures, in accordance with anembodiment.

FIG. 32 is a side perspective view of needle according to certainaspects of the disclosure, in accordance with an embodiment.

FIG. 33 is a perspective view of a pledget delivery handle according tocertain aspects of the disclosure, in accordance with an embodiment.

FIG. 34A is a top rear perspective view of a stabilization system and asuture management system in accordance with certain aspects of thepresent disclosure, in accordance with an embodiment.

FIG. 34B is a top side perspective view of the stabilization system andthe suture management system of FIG. 34A, in accordance with anembodiment.

FIG. 35 is aside view of the stabilization system and the suturemanagement system of FIG. 34A, in accordance with an embodiment.

FIG. 36 is a top view of the stabilization system and the suturemanagement system of FIG. 34A, in accordance with an embodiment.

FIG. 37 is a closer top view of the rear portion of the stabilizationsystem and the suture management system of FIG. 34A, in accordance withan embodiment.

FIG. 38 is a closer review view of the stabilization system and thesuture management system of FIG. 34A, in accordance with an embodiment.

FIG. 39 is a distal end perspective view of an alternate leaflet anchordeployment needle, in accordance with an embodiment.

FIG. 40 is a schematic block diagram of a system to provide asynchronized control signal based upon detection of a preselected pointin the cardiac cycle, in accordance with an embodiment.

FIG. 41 is a schematic block diagram of a trigger generator used in thesystem shown in FIG. 23 , in accordance with an embodiment.

FIG. 42 is a schematic block diagram of an actuator firing circuit usedin the system shown in FIG. 40 , in accordance with an embodiment.

FIG. 43 is a schematic block diagram of an actuator unit used in thesystem shown in FIG. 40 , in accordance with an embodiment.

FIG. 44 illustrates an ECG signal, marker pulse, trigger pulse andfiring pulse waveforms occurring in the system depicted in FIG. 40 , inaccordance with an embodiment.

FIG. 45 illustrates a touch sensitive monitor which may be used in thedevice depicted in FIG. 40 , in accordance with an embodiment.

FIG. 46 is a schematic side perspective view of a heart with atranscatheter mitral chordal repair system in accordance with aspects ofthe present disclosure, in accordance with an embodiment.

FIG. 47 is a cut-away side perspective view of a suture cutter mechanismin accordance with aspects of the present disclosure, in accordance withan embodiment.

FIG. 48 depicts motion of a pledget suture and a suture lock in certaintranscatheter mitral chordal repair systems, according to aspects of thepresent disclosure, in accordance with an embodiment.

FIGS. 49 and 50 illustrate movement of sutures and a suture lock,according to aspects of the present disclosure, in accordance with anembodiment.

FIG. 51 illustrates an anchor, retaining member, and suture lock of atranscatheter mitral chordal repair system in which an upper portion ofthe anchor extends along a portion of the outer surface of the retainingmember, according to aspects of the present disclosure, in accordancewith an embodiment.

FIG. 52 illustrates a cut-away view of the transcatheter mitral chordalrepair system of FIG. 51 , with the suture lock located within theretaining member, in accordance with an embodiment.

FIG. 53 illustrates an orientation of a suture lock, retaining member,and anchor according to aspects of the present disclosure, in accordancewith an embodiment.

FIG. 54 illustrates an orientation of a suture lock and suture,according to embodiments of the present disclosure, in accordance withan embodiment.

FIG. 55 illustrates an anchor, retaining member, and suture lock of atranscatheter mitral chordal repair system in which the anchor extendsover an anchor hub, according to embodiments of the present disclosure,in accordance with an embodiment.

FIGS. 56, 57 and 58 illustrate an anchor, retaining member, and suturelock of a transcatheter mitral chordal repair system in which the anchoris advanced out of the retaining member and into adjacent tissue, inaccordance with an embodiment.

FIGS. 59 and 60 illustrate an anchor, retaining member, and suture lockof a transcatheter mitral chordal repair system in which an anchorpledget is located between the suture lock and the anchor hub, accordingto aspects of the present disclosure, in accordance with an embodiment.

FIG. 61 illustrates a side cutaway view of a retaining member, accordingto aspects of the present disclosure, in accordance with an embodiment.

FIG. 62 illustrates a side cutaway view of an upper portion of aretaining member, according to aspects of the present disclosure, inaccordance with an embodiment.

FIG. 63 illustrates a retaining member including a densified portionthat secures an anchor hub, aspects to embodiments of the presentdisclosure, in accordance with an embodiment.

FIG. 64 illustrates a cutaway view of the socket of FIG. 63 , inaccordance with an embodiment.

FIG. 65A illustrates a side perspective view of a socket, according toaspects of the present disclosure, in accordance with an embodiment.

FIG. 65B illustrates a top cutaway view of the socket of FIG. 65A, inaccordance with an embodiment.

FIG. 66 is a schematic illustration of an anchor, retaining member, andsuture lock according to aspects of the present disclosure, inaccordance with an embodiment.

FIG. 67 illustrates an orientation of a prosthetic chord, according toaspects of the present disclosure, in accordance with an embodiment.

FIG. 68 is a side perspective view of a suture lock and lock drivermechanism in accordance with embodiments of the present disclosure, inaccordance with an embodiment.

FIG. 69 is a side perspective view of a suture lock after tightening andinitial dis-engagement of a lock driver mechanism and boot in accordancewith aspects of the present disclosure, in accordance with anembodiment.

FIG. 70 is a side perspective view of the configuration of FIG. 69 uponfurther dis-engagement of the lock driver and boot in accordance withaspects of the present disclosure, in accordance with an embodiment.

DETAILED DESCRIPTION

U.S. patent application Ser. No. 15/858,671, filed Dec. 29, 2017 (theentirety of which is hereby incorporated by reference herein disclosessystems and methods for the transvascular prosthetic chordae tendinaeimplantation. One aspect involves advancing a catheter into the leftatrium, through the mitral valve, and into the left ventricle; deployinga ventricular anchor from the catheter and into a wall of the leftventricle, leaving a ventricular suture attached to the ventricularanchor and extending proximally through the catheter; and advancing aleaflet anchor into a mitral valve leaflet to secure the mitral valveleaflet to a leaflet suture, with the leaflet suture extendingproximally through the catheter, and extending the leaflet suture overthe top of the coaptive edge and securing the leaflet suture to theventricular suture to limit a range of travel of the leaflet in thedirection of the left atrium. Certain aspects are developed furtherherein.

The approach to the mitral valve can be accomplished through a standardtransseptal approach to provide access to the left atrium. With thisaccess, a first step can include securing a leaflet capture catheter tothe leaflet of the mitral valve in the location determined to bestcorrect regurgitation. Probing the surface of the leaflet from thesuperior atrium surface can advantageously provide immediate feedback asto the optimal location to add an additional mitral valve chord. Inanother implementation of the disclosure, the ventricular anchor isdeployed first, followed by deployment of the leaflet anchor.

Referring to FIG. 1 , a ventricular anchor such as a helical anchor 32has been deployed near the apex 20 of the left ventricle 24. While thehelical anchor 32 is shown positioned near the apex 20 in the followingFigures, the anchor 32 can be attached at a point that is offset fromthe thin tissue of the apex, and can be instead implanted in thegenerally thicker adjacent wall of the ventricle, such as between thetwo papillary muscles. This allows the implanted neo chord construct(suture, optional neo papillary muscle, and/or the helical anchor) to bealigned along a longitudinal axis substantially parallel to orconcentric with the original path of the native chord. In certainembodiments, the implanted neo chord construct is aligned along alongitudinal axis that is within 5 degrees, 10 degrees, or 15 degrees ofbeing parallel with the original path of the native chord and/or thepath of the adjacent native chord. In addition, while a helical anchoris illustrated the anchor can have a different structure for engagingtissue of the heart and thus other tissue anchor structures can be usedinstead of a helical structure including various piercing, hook orradially expandable structures known for engaging tissue.

Referring to FIGS. 2A and 2B, there is illustrated one implementation ofa tissue anchor suitable for use as a ventricular anchor in accordancewith an aspect of the present disclosure. The anchor assembly 50 will bedescribed primarily in the context of the present chordae repairapplication, however the anchor may be utilized in any of a wide varietyof other applications where a soft tissue or bone anchor may be desired.

The anchor assembly 50 generally comprises a coil 54 which may compriseany of a variety of materials such as stainless steel or Nitinol. Thecoil 54 extends helically between a proximal end 56 and a distal end 58.Distal end 58 is provided with a sharpened tip or tissue piercing point59, and also carries a retention barb 61, configured to resist reverserotation of the coil and detachment from tissue. The proximal end 56 ofthe coil 54 is carried by (attached to or formed integrally with) a hub57 discussed in additional detail below.

Extending distally from the hub 57 and within the coil 54 is an elongatecore wire 62 having a sharp, tissue piercing distal end 64. The distalend 64 is positioned distally of the distal end 58 of the coil 54. Thisenables the sharp distal end 64 to pierce tissue upon contact, and priorto beginning rotation of the coil 54 to embed the coil 54 within thetarget tissue. Engaging the tip 64 prior to rotation of the anchorstabilizes the anchor against sideways movement allowing a singleplacement of the anchor 50 against tissue, and rotation of the coil 54to engage tissue, without ‘walking’ of the anchor away from the desiredtarget site as will be understood by those of skill in the art. Aproximal end of the core wire 62 may be attached to the hub in any of avariety of ways, such as by soldering, brazing, adhesives and/ormechanical interference such as by entering an aperture in a sidewall orother surface of the hub 57.

A radiopaque depth marker 66 is provided with an aperture 68 and isaxially movably carried on the core wire 62. A distal stop 70 such as aradially outwardly extending protrusion or annular ridge is carried bythe core wire 62, and spaced proximally of the sharpened distal end 64to provide a core wire leading segment 72 on the distal side of the stop70 so that the marker 66 cannot interfere with the tissue anchoringfunction of the distal tip 64. The stop 70 functions to limit distaltravel of the marker 66. The marker 66 may be an annular structure suchas a circular disc with a central aperture to receive the core wire 62.

A coil spring 71 is concentrically carried over the core wire 62 andbiases the radiopaque marker 66 in the distal direction. The radiopaquemarker 66 is thus held in position against a proximal surface of thestop 70. In use, the marker 66 rides on the surface of tissue at thetarget attachment site. As the helical coil anchor 54 is rotated andadvances distally into tissue, the marker 66 rides proximally on thecore wire 62 along with the tissue surface, compressing the coil spring71 until the marker 66 is retracted proximally to the hub when thetissue anchor is fully embedded. This enables fluoroscopic visualizationof the progress of the coil into tissue and of the fully engaged endpoint of embedding the coil 54 into the target tissue, by observing thechanging distance between marker 66 and a reference such as the hub 57or other radiopaque marker.

The hub 57 comprises a proximal connector for engagement with arotational driver as discussed elsewhere herein. In one implementation,the connector comprises an aperture such as a hexagonal aperture forremovably engaging a complementary surface structure on the distal endof the driver. A suture 74 is secured to the anchor assembly 50, forexample secured to the hub 57, coil 54 or core wire 62. In theillustrated embodiment, the suture 74 is attached to a cross pin 76which may be inserted through one or two apertures in the sidewall ofthe hub and across a central hub lumen. The suture may additionallycarry one or two or more radiopaque markers 82 spaced apart from the hub57, and may extend proximally through the proximal connector and acentral lumen in the rotational driver.

A suture lock guide such as a tubular sleeve 78 extends proximally fromthe hub 57 for at least about 2 mm or 4 mm or 8 mm but generally no morethan about 5 cm or 2 cm depending upon desired performance. In certainexample embodiments, a suture lock guide such as a tubular sleeve 78extends proximally from the hub 57 for at least 2 mm or 4 mm or 8 mm butgenerally no more than 5 cm or 2 cm depending upon desired performance.The guide sleeve 78 may comprise a flexible material such as ePTFE. Aradiopaque marker band 80 may be carried by the proximal end of sleeve78 and spaced axially apart from the marker 82 on suture 74, tofacilitate fluoroscopic visualization of the suture lock as it isadvanced distally over the suture 74. The marker band 80 may bepositioned in between an inner layer and an outer layer of ePTFE sleeve,such as may result from placing the band over the sleeve and invertingthe sleeve over itself to entrap the ring.

The suture lock guide may comprise any of a variety of structures suchas a sleeve as illustrated or an alignment pin extending proximally fromthe hub and received within a lumen in the suture lock, for maintainingthe orientation of the suture lock following detachment from thedeployment catheter. Since the tension on the suture is optimized whilethe suture lock is held in place by the deployment catheter, any changein the orientation of the suture lock following release from thecatheter would affect tension on the leaflet and potentially negativelyaffect the therapeutic value of the implant. The suture lock guide helpsmaintain constant the maximum distance between the ventricular anchorand the leaflet anchor both pre and post deployment from the catheter.In this manner the maximum tension on the leaflet suture (duringsystole) remains unchanged after the suture lock has been locked, bothbefore and after detachment of the catheter.

The helical anchor assembly 50 may be delivered by a ventricular anchordelivery subsystem 300. FIGS. 2C-2E illustrate various views of aventricular anchor delivery subsystem 300 and its components. FIG. 2Cdepicts a perspective view of a distal end of the subsystem 300. FIG. 2Ddepicts a perspective view of a proximal end of the subsystem 300. FIG.2E depicts a partially exploded view of a distal end of the subsystem300.

The subsystem 300 may be delivered through the delivery catheter 100.The delivery catheter 100 may access the left atrium throughconventional techniques, such as through an atrial trans-septalpuncture. The delivery catheter 100 may be maintained in a substantiallyconstant location throughout the procedure as various subsystems areplaced and removed from the delivery catheter 100. For instance, thedistal end of the delivery catheter 100 may be positioned in the leftatrium. In other implementations, the distal end of the deliverycatheter 100 may be positioned in the left ventricle throughout theduration of the procedure.

As shown in FIGS. 2C-2E, the ventricular anchor delivery subsystem 300may comprise an outer sheath 304, a driver (comprising shaft 307 andhead 306), an anchor hub 308, and an anchor 302. The anchor may be ahelical anchor 302 and the drive head 306 can be configured to rotatethe helical anchor 302. The helical anchor 302 may comprise an innerdiameter configured to be received over the outer diameter of an anchorhub 308. The helical anchor 302 may be securely fixed secured to theanchor hub 308 by an interference fit or other frictional engagement,soldering or other known attachment technique. The anchor hub 308 may beleft implanted along with the helical anchor 302.

The anchor hub 308 may comprise a lumen positioned substantially along acentral axis of the anchor hub 308 for receiving a suture 74 (FIG. 2A)and attaching the suture 74 to the helical anchor 302. In someembodiments, the suture 74 may comprise an attachment element (e.g. aknot or a washer) with a diameter sized to prevent the suture 74 frombeing pulled proximally through the anchor hub 308 lumen. For example,the suture 74 may be knotted on a distal side of the lumen. In someembodiments, the suture 74 may be tied to the anchor hub 308 (e.g.,passed through the lumen, wrapped around a structure such as the outersurface or a cross pin 76 as shown in FIG. 2B, and tied to itself).

The helical anchor 302 may comprise a distal section of windings and aproximal section of windings. The proximal section of windings may bespaced closer together than the distal section of windings and may beconfigured for securing the helical anchor 302 to the anchor hub 308.The distal section of windings may be spaced further apart than theproximal section of windings and may be configured for insertion intothe ventricular tissue. The anchor hub 308 may comprise an enlargedcross-section at its proximal end configured to abut the helical anchor302 and/or prevent the helical anchor 302 from advancing proximally overthe proximal end of the anchor hub 308. Other helical anchors, such asthose described elsewhere herein, may be configured to be used with theventricular anchor delivery subsystem 300 described herein as well.

The proximal face of the helical anchor 308 may comprise a recess forreceiving an extending portion 306′ of the driver head 306. The recessmay be non-circular (e.g., oblong or polygonal such as hexagonal) suchthat it is configured to transfer torque from the driver to the anchorhub 308 upon rotation of the driver. The recess may be positioned aroundthe central lumen of the anchor hub 308.

In other embodiments, the anchor hub 308 may comprise an extendingportion and the driver 306 may have a complementary recess. The driverhead 306 may be generally cylindrical, with a distally facing post oraperture with a complementary configuration to rotationally engage thecorresponding component on the anchor. The driver head 306 may befixedly coupled to a drive shaft 307. The driver may comprise a centrallumen through the driver head 306 and drive shaft 307 configured toreceive the suture 74. The central lumen of the driver may be configuredto be aligned with the central lumen of the anchor hub 308. The driveshaft 307 may be received within a guide shaft 305. The diameter of thedriver head 306 may be larger than the inner diameter of the guide shaft305. The outer sheath 304 may be sized to receive the guide shaft 305 aswell as the driver head 306, the anchor hub 308, and the helical anchor302.

The outer sheath 304 may be delivered into the left ventricle andproximal to the ventricular attachment site via the delivery catheter100. In some embodiments, the outer sheath 304 may be delivered withouta delivery catheter. In some implementations, the helical anchor 302 maybe concealed within the outer sheath 304 until the outer sheath 304 ispositioned proximal to the ventricular attachment site then pusheddistally through the outer sheath 304 or the outer sheath 304 isproximally retracted so that the helical anchor 302 is exposed. Thehelical anchor 302 may be placed into contact with the ventriculartissue. Rotation of the drive shaft 307 may cause the driver head 306,the anchor hub 308, and the helical anchor 302 to rotate therebyscrewing the ventricular anchor 302 into the ventricular tissue.Rotation of the driver 309 may axially advance the driver 309, anchorhub 308, and helical screw 302 in a distal direction with respect to theouter sheath 304.

The drive shaft 307 may be rotated manually by a user using a drivehandle 312, as shown in FIG. 2D. The proximal end of the ventricularanchor delivery subsystem 300, as illustrated in FIG. 2D, may comprisefirst and second hemostasis valves 314, 316. The first hemostasis valve314 may be positioned distal to the drive handle 312 and may provideaccess to the guide shaft 305. The second hemostasis valve 316 may bepositioned proximal to the drive handle 312 and may provide access tothe central lumen of the driver. The ventricular anchor suture (notshown) may extend through the second hemostasis valve 316.

In some implementations, the inserting portion 306′ of the driver head306 and the recess of the anchor hub 308 may have a frictionalengagement that transiently holds the two components together. Thefrictional engagement may be overcome upon proximal retraction of thedriver by a counter force from the ventricular tissue once the helicalanchor 302 is inserted. In some implementations, proximal tension on thesuture 74 may provide an engagement force between the proximal hub 308and the driver head 306, which can be released upon retraction of thedriver 309. The driver head 306 may be proximally withdrawn into theouter sheath 304 before the outer sheath 304 is withdrawn into thedelivery catheter 100.

The non-implanted components of the ventricular anchor deliverysubsystem 300 may be removed from the delivery catheter 100 andsubsequent subsystems may be placed in the delivery catheter 100 forcompleting implantation of the neo chordae. In a modified embodiment,the ventricular anchor delivery subsystem 300 and subsequent subsystemssuch as the leaflet anchor delivery subsystem 330 may be positionedwithin the delivery catheter 100 at the same time and in certainarrangements the tissue and leaflet anchors can both be preloaded intothe delivery catheter. In alternative embodiments, the implantation ofthe ventricular anchor may be performed in a different order (e.g.,after the implantation of the leaflet anchor). The ventricular anchordelivery components may be proximally retracted over a proximal end ofthe suture 74, which may remain extending through the delivery catheter100 to the ventricular anchor 302.

In certain implementations of the present disclosure, it may bedesirable to provide a secondary anchor to prevent the helical coil 54of the ventricular anchor 32 from reverse rotation post implantationwhich can cause the helical coil 54 to become disengaged from theattachment site. In general, the secondary anchor can be advanceablefrom a first configuration such as for transluminal navigation andattachment of the primary, helical anchor, to a second, deployedconfiguration for engaging tissue and inhibiting unscrewing of thehelical anchor 54 from the attachment site.

In certain embodiments, the secondary anchor may be deployed into thesecond configuration automatically in response to full engagement of theprimary helical anchor. Alternatively, the secondary anchor may bedeployed by manual manipulation of a control or distal advance of apusher by the attending clinician. The pusher may be in the form of atubular body axially movably carried over the anchor driver.Alternatively, the pusher may comprise the anchor driver. In suchimplementations, the anchor driver may be provided with an engagementsurface structure such as a ratchet which cooperates with acomplementary surface structure on a radially inwardly facing surface ofthe secondary anchor assembly. The anchor driver may be proximallyretracted without affecting the secondary anchor, but subsequent distaladvance of the anchor driver deploys the secondary anchor. The pushermay alternatively comprise the suture lock catheter, as discussedfurther below.

Embodiments of the secondary anchor described above and with respect toFIGS. 2F and 2G can be used independently and/or in combination withfeatures and aspects of the ventricular anchor 32 described herein andwith respect to the embodiments described with respect to FIGS. 2A-2E.

FIGS. 2F and 2G illustrate an embodiment of the ventricular anchor 32that can include a secondary anchor 110. In the illustrated embodiment,the secondary anchor 110 comprises at least a first tine 112 extendingbetween a proximal end 114 and a distal sharpened end 116. The tine 112may be carried by a support 118, such as by connection to proximal end114. Support 118 can facilitate axial advancement of the tine 112. Inthe illustrated embodiment, the support 118 comprises an annularstructure having an aperture 120, such as a ring 122. The aperture 120is configured to axially movably receive the anchor driver (notillustrated), or other tubular structure or component that may be a partof the anchor deployment system.

The hub 57 is provided with at least a first tine guide 124, such as anaperture or lumen, for axially movably receiving the first tine 112therethrough. The first tine guide 124 may include a deflection surfacefor deflecting the tine 112 into a launch angle that inclines radiallyoutwardly in the distal direction. The launch angle measured at the exitfrom the tine guide 124 may be within the range of from about 30 degreesto about 45 degrees, and in some implementations within the range offrom about 35 degrees to about 40 degrees from the central longitudinalaxis of the anchor. In certain example embodiments, the launch anglemeasured at the exit from the tine guide 124 may be within the range offrom 30 degrees to 45 degrees, and in some implementations within therange of from 35 degrees to 40 degrees from the central longitudinalaxis of the anchor.

As an alternative or in addition to the deflection surface, the tine maybe pre biased radially outwardly, so that it ramps outwardly as it isadvanced out of the tine guide 124. Distal advance of the first tine 112advances the tine through the first tine guide, distal of which the tine112 extends radially outwardly in a distal direction to expose a lengthof tine of at least about 1 mm or 2 mm or 3 mm or 4 mm or more,depending upon the desired performance. In certain example embodiments,distal advance of the first tine 112 advances the tine through the firsttine guide, distal of which the tine 112 extends radially outwardly in adistal direction to expose a length of tine of at least 1 mm or 2 mm or3 mm or 4 mm or more, depending upon the desired performance. Measuredperpendicular to the longitudinal axis, the distal tip 116 of the fullydeployed tine is at least about 1 mm or 2 mm or 3 mm or 4 mm or morefrom the outer surface of the helical coil 54. In certain exampleembodiments, measured perpendicular to the longitudinal axis, the distaltip 116 of the fully deployed tine is at least 1 mm or 2 mm or 3 mm or 4mm or more from the outer surface of the helical coil 54. The distal tip116 upon full deployment may be spaced laterally from the helical coilby at least about 50% or 75% or 100% or more of the outside diameter ofthe helical coil. In certain example embodiments, the distal tip 116upon full deployment may be spaced laterally from the helical coil by atleast 50% or 75% or 100% or more of the outside diameter of the helicalcoil.

The tine 112 may comprise any of a variety of materials such asstainless steel or Nitinol, having sufficient structural integrity toresist rotation and/or be capable of holding a bias. The tine 112 maycomprise a flat ribbon or round wire, and in one implementation,comprises 0.016″ stainless steel round wire.

Distal advancement of the first tine 112 may be accomplished by applyingdistal pressure on the support 118, such as by a secondary anchordeployment pusher or catheter advanced over the suture 74 and/or anchordriver discussed elsewhere herein. Alternatively, the secondary anchor110 may be deployed by advancing the suture lock distally over thesutures and into contact with the support 118, and further to advancethe support 118 distally to entrap the support 118 in between the distalend of the suture lock and the hub 57. In this manner, the suture lockcan serve as a secondary anchor lock to preventing or inhibit thesecondary anchor from backing away from the deployment site.

A second tine 126 may be provided, extending through a second tine guide128 and connecting to the support ring 122. Three or four or more tinesmay be provided, depending upon desired performance of the secondaryanchoring system. In the illustrated embodiment, two tines are shown,spaced at approximately 180 degrees apart around the circumference ofthe helical anchor. In a three tine embodiment, the tines may beequidistantly spaced at approximately 120 degree intervals.

As illustrated, the tine guides 124, 128 can direct the tines 112, 126through the fabric of the tubular suture anchor guide. The fabric may beprovided with an aperture aligned with the path of the tine, or the tinemay pierce the fabric during deployment. The exit path of the tines canbe moved distally if desired, such that the tines extend axially throughthe hub and into the helical coil, and exit laterally between two spacedapart adjacent windings of the coil. The tines and/or the support 118may comprise a radiopaque marker or material to enable fluoroscopicconfirmation of full deployment.

The use one or more secondary anchors 110 can increase the anchor torqueresistance of the helical coil 54 to inhibit or prevent the helical coil54 of the ventricular anchor 32 from reverse rotation post implantation.Such reverse rotation after implantation can cause the helical coil 54to become disengaged or loosen from the attachment site. In someembodiments, the secondary anchors 110 can increase the torqueresistance of the ventricle anchor 32 by at least a factor of 2, 4, 6, 8or 10 compared to the use of the ventricular anchor 32 without thesecondary anchor 110. In certain embodiments, the addition of one ormore of the secondary anchor 110 can increase the torque resistance by afactor of 2 to 10 as compared to the use of a ventricular anchor 32 byitself and in certain embodiments the one or more of the secondaryanchor can increase torque resistance by a factor of 2 to 5. In suchembodiments, more than one tine of the secondary anchor can be used andin certain embodiments 2, 3, 4, or 5 the secondary anchor can be used,which can be in the form of tines 112, 126 as described above. In someembodiments, the torque resistance with the one or more secondary anchor110 can be greater than 2 N/cm. In some example, the torque resistancewith the addition of one or more tines of the secondary anchor 110 canbe at least between 2 N/cm to 5 N/cm.

Additionally, the use of one or more of the secondary anchor 110 canincrease the torque stiffness of the helical coil 54 to prevent and orinhibit wobbling or shifting, which can also prevent the helical coil 54of the ventricular anchor from becoming disengaged from the attachmentsite. For example, the secondary anchor 110 can increase the torquestiffness by at least a factor of 2, 4, 6, 8 or 10 compared to the useof the ventricular anchor without the secondary anchor 110 and incertain embodiments the secondary anchor can increase the torquestiffness by a factor of between 2 to 10 as compared to the ventricularanchor without the secondary anchor 110 and in certain embodiment by afactor of 3 to 8. In such embodiments, more than one secondary anchorcan be used and in certain embodiments 2, 3, 4, or 5 secondary anchors110 are used and in certain embodiments the secondary anchors can be inthe form of tines 112, 126 as described above. In certain embodiment,the torque resistance with the one or more the secondary anchor 110 canbe greater than 0.02 N-cm/deg. In some example, the torque resistancewith the one or more secondary anchors 110 can be between 0.01 N-cm/degto 0.03 N-cm/deg.

In some examples, the one or more tines of the secondary anchors 110 caneach be at least 5 mm in length as measured from the hub 57. In someexamples, the one or more tines of the secondary anchors 110 can each bebetween 1 mm to 8 mm in length, in certain embodiments between 4 and 7mm in length and in certain embodiments 5 mm in length. The widthbetween any two tines of the secondary anchor 110 can be approximately12 mm. In some examples, the width between any two tines can be between5 mm to 15 mm. The length and width of the tines advantageously allowsthe tines of the secondary anchor 110 to extend into the pericardialspace without perforating through the ventricle wall, while stillproviding adequate torque resistance and stiffness.

The thickness of each tine can be approximately 0.3 mm. In someexamples, the thickness of each tine can be between 0.1 mm to 0.5 mm.This thickness of the tines can provide adequate bend or yield as thetines are advanced.

Further, the angle of each tine from the centerline of the helical coil54 can be approximately 40 degrees. In some examples, the angle of eachtine from the centerline of the helical coil 54 can be between 25degrees to 60 degrees. This angle can advantageously be extend toprovide the desired torque resistance and stiffness while notperforating the ventricle wall. This can also provide the desiredorientation of each tine pointing towards the mitral valve when theanchor is positioned at an angle in the ventricle wall.

The end of each tine can be optionally coined along its length. This canprevent the secondary anchor from pulling back too far into the hub 57by catching the coined portion distal to the respective tine guide 124or holes in the hub 57 that the tines pass through.

FIGS. 3-6 depict the deployment of the leaflet anchor. Referring to FIG.3 , the ventricular anchor 32 has been deployed and is tethered to thecatheter 100 by a ventricular anchor suture 74 and the ventricularanchor subsystem has been removed. The leaflet anchor is carried withina needle 338, shown aimed at a target site on the atrial side of theleaflet. The needle 338 is axially reciprocally carried within thecatheter 100, such as within a tubular sleeve or leaflet anchor catheter332 advanceable through the catheter 100. Additional details of theneedle and needle driver are discussed below.

As shown in FIG. 3 , in the illustrated arrangement, the needle cancross through the leaflet from the atrium to the ventricle and apreloaded suture can then be advanced into the ventricle. The suture canthen be used to collapse the pledget against the ventricular side of theleaflet to anchor the suture to the leaflet as shown in FIG. 4 . Thusthe pledget forms a radially enlargeable leaflet anchor. In certainembodiments, other forms of a radially enlargeable leaflet anchor can beused.

The leaflet anchor and suture can then be used in combination with aventricular anchor, suture and suture lock to effectively create a newmitral chord as shown in FIG. 5 . As noted above, the leaflet anchor andsuture can be used in combination with the systems and methods for thetransvascular prosthetic chordae tendinae implantation disclosed in theU.S. patent application Ser. No. 15/858,671 (the entirety of which isincorporated by reference herein) and the various embodiments ofventricular anchors, sutures and suture locks disclosed therein.

The leaflet anchor deployment subassembly may be provided with atemporary anchor for capturing and stabilizing the leaflet while theneedle tip 338 is advanced therethrough at a target side. As illustratedin FIG. 3 and FIG. 4 , a distal end 400 of delivery tube 332 or othersystem component carries a temporary tissue anchor such as a helicaltissue anchor 402. Anchor 402 may be similar to ventricular anchor 54except that temporary anchor 402 does not have a distal barb since it isintended to be only momentarily in engagement with the leaflet. Theanchor 402 thus comprises a helical element 406 which terminates in adistal tip 408.

In use, the distal tip 408 is positioned at a target site on the surfaceof the leaflet, and the helical element 406 is rotated about or aroundits axis to engage and penetrate the leaflet. The needle tip 338 may beoptionally engaged with the leaflet prior to rotation of the helicalelement 406, and utilized to stabilize the anchor against moving awayfrom the target site in response to rotation, in a manner similar tothat discussed in connection with the ventricular anchor and FIGS. 2Aand 2B.

Following engagement of the helical element 406 to capture the leafletfrom the atrial side and secure the leaflet to the catheter, the needlemay be advanced distally through the central lumen defined by thehelical element 406 and completely through the leaflet so that theneedle tip 338 exits the ventricular side of the leaflet as seen in FIG.4 . An anchor deployment actuator such as a pusher extending through theneedle may be utilized to deploy the anchor from the needle and into theventricle.

Referring to FIG. 5 , the leaflet anchor may be a pledget 340 similar tothose described elsewhere herein. The pledget 340 may be coupled orattached to the distal end of a leaflet anchor suture 344. The pledgetmay comprise a soft and/or flexible material such as a fabric. Thesuture 344 may extend through the needle 336. The pledget 340 may befolded or compressed in a conformation comprising a reduced radial crosssection such that it may be disposed within the needle 336 for delivery,as shown in FIGS. 8 and 10 discussed below. The pledget 340 may expandfrom a reduced cross section to assume a larger radial cross sectionupon deployment from the distal end of the needle tip 338, as shown inFIG. 5 . In some embodiments, the pledget 340 may be pushed through theneedle 336 via a push wire or release wire (not shown). Upon deliverythrough the needle tip 338, proximal retraction of the leaflet suture344 as shown in FIG. 6 may cause the leaflet anchor to assume an axiallycollapsed, radially enlarged conformation which prevents the leafletanchor from being retracted through the puncture in the leaflet andthereby anchors the leaflet suture 344 to the leaflet, as shown in FIG.7 .

FIGS. 6A-6D schematically depict a pledget 340 connected to the distalend of a leaflet suture 344. The pledget 340 may comprise two wings 341,342, which may be rolled/folded (e.g., both in a clockwise orcounterclockwise direction) around a longitudinal axis of the pledget340 to form a reduced cross section conformation. In some embodiments,the leaflet suture 344 may be integrally formed with the pledget 340. Inorder to produce a foldable or collapsible configuration, the suture 344may extend distally through the pledget, loop around the distal end ofthe pledget and return proximally and threaded back through one or moreapertures (e.g., two apertures, three apertures, four apertures, etc.)formed in the pledget 340, as shown in FIG. 6A. In some embodiments, theapertures may be aligned along a center of the pledget 340.

The apertures may extend through the pledget 340 and through the portionof the embedded portion of the suture 344 which is integral with thepledget 340. The embedded portion of the suture 344 may be at leastpartially flatted within the pledget 340. In some embodiments, theapertures may be placed substantially near the center of the pledget(e.g., immediately to the left or right of the embedded suture 344 oralternating between the left and right side of the suture 344). Whendeployed the suture 344 may be effectively joined to a distal end of thepledget 340 (e.g., the suture 344 may loop back to where it insertsbetween the pledget sheets).

FIGS. 6B-6D schematically depict an example of a pledget as describedelsewhere herein. FIG. 6B schematically depicts a pledget 340 formed byaffixing a distal end (shown in dashed lines) of the suture 344 betweentwo flat sheets, such that the sheets for left and right wings 341, 342.FIG. 6C shows a cross-section of the pledget 340 along the axis of B-Billustrated in FIG. 6B. In some embodiments, the suture 344 may beinserted between two sheets (e.g., substantially down the middle of thesheets) and pressed and/or laminated to join the three componentstogether (e.g., under heat and/or pressure). At least one of the layersmay be partially sintered. The suture 344 may be flattened and/ordensified to improve resistance to suture tear out. The sheets may beflat polytetrafluoroethylene (PTFE) sheets (e.g., thin uncured expandedPTFE (ePTFE) sheets) or any other suitable material. In someimplementations, the leaflet suture 344 may be disposed between thesheets in alternative configurations, such as a zig-zag or s-shapedconfiguration. FIG. 6D shows the pledget 340 of FIG. 6B comprising aplurality of apertures 343 through which the proximal tail end of thesuture 344 may be threaded through.

In some embodiments, one or more apertures 343 may be formed through thepledget, in various configurations, to form a collapsible structure, asdescribed elsewhere herein, which is configured to anchor the suture 344against the mitral leaflet. FIG. 6D shows apertures 343 alternatingaround opposing sides of the suture 344. In some embodiments, theapertures 343 may be formed on the same side of the suture 344 (e.g., inwing 341 or wing 342). In some embodiments, the apertures 343 may beformed through the suture 344. The apertures 343 may be aligned along acenter of the pledget 340. The apertures 343 may be aligned along thelength of the suture 344 (e.g., may form a straight line). The suture344 may be at least partially flattened between the two opposing sheets,which may facilitate the placement of apertures 343 through the suture344. Various combinations of apertures 343, including the positioningdescribed above, may be used.

The pledget 340 may be formed such that the wings 341, 342 areapproximately the same size or they may be formed to be different sizes.Upon proximal retraction of the leaflet suture 344, the pledget 340 maybe folded to assume an accordion-like conformation, as depicted in FIG.6A. The pledget 340 may assume a conformation comprising a substantiallyplanar proximal surface which is approximately perpendicular to thelongitudinal axis of the leaflet suture 344. This conformation mayfacilitate anchoring the suture 344 in the leaflet. Upon anchoring theleaflet suture 344 in the leaflet, the leaflet anchor delivery subsystem340 may be withdrawn from the delivery catheter 100. The leaflet anchordelivery components may be proximally retracted over a proximal end ofthe suture 344, which may remain extending through the delivery catheter100 to the leaflet anchor 340, alongside the ventricular anchor suture74.

FIGS. 8-10 illustrate various views of the leaflet anchor deliverysubsystem 330 and its components. FIG. 8 depicts a perspective view of adistal end of the subsystem 330. FIG. 9 depicts a perspective view of aproximal end of the subsystem 330. FIG. 10 depicts an exploded view ofthe distal end of the subsystem 330.

As shown in FIGS. 8 and 10 , the leaflet anchor delivery subsystem 330may comprise an outer delivery tube 332. The tube 332 may optionallyinclude a deflection zone and may be configured to be steerable by anoperator such as by proximal retraction of one or two or more pull wires(not shown) along various sides of the flex tube 332. The operator maycontrol the flexion of the flex tube via a knob 352 or lever or otheractuation mechanism positioned on a handle 350 at the proximal end ofthe leaflet anchor delivery subsystem 330, as shown in FIG. 9 .

An internal tubular shaft or needle 336 terminating at a distal end witha needle point 338 may extend through the delivery tube 332. Theinternal needle 336 may comprise a hypotube, extrusion or braided tubeor catheter which is flexible enough to conform to the shape of theoptional flex tube 332. A needle tip 338 may be coupled to the distalend of the internal flexible shaft 336. A flexible jacket 333 maysurround the flex tube 332 and a delivery shaft 334.

The proximal end of the internal tubular shaft 336 may be connected to aneedle handle 354, as shown in FIG. 9 . The needle handle 354 maycomprise a hemostasis valve 356. The leaflet suture 344 may be insertedthrough valve 356. Valve 356 may be a tuohy-borst valve. The needlehandle 354 may include additional ports 358 for accessing the lumen ofthe internal flexible shaft 336. The needle handle 354 may be positionedproximally to the handle 350 such that the internal flexible shaft 336extends through the handle 350 and into the lumen of the delivery shaft334. The handle 350 may comprise a hemostasis valve for receiving theinternal flexible shaft 336 and sealing the internal components of thehandle, including the opening to the delivery shaft 334, from theambient environment.

The needle tip 338 may be extendable and retractable by extending theneedle handle 354 toward the handle 350 or retracting the needle handle354 from the handle 350, respectively. Distal advance of the needle 336may be accomplished by manually advancing the handle 354. Alternatively,the distal advance of the needle may be assisted by a mechanical orelectromechanical mechanism to produce a relatively high velocity, lowstroke length distal advance.

Exertion of pressure on the leaflet when the needle tip 338 is extendeddistally beyond the tube 332 may cause the needle tip 338 to puncturethe leaflet such that the needle tip 338 may extend through to theopposite side (e.g., the atrial side) of the leaflet, as shown in FIG. 4. This pressure may be exerted by extending the needle tip 338 and/orretracting the entire delivery device 330 in a proximal direction withthe needle tip 338 in an extended position.

The ventricular anchor suture 74 and the leaflet anchor suture 344 maybe coupled together in a tensioned fashion to form the neo chordaeimplant or to join two sections of the neo chordae implant together,such that the neo chordae extends between the ventricular anchor 302 andthe leaflet anchor 340 across the atrial side of the coaptive edge ofthe leaflet. The overall length of the neo chordae may be adjusted byproximal traction of one or both sutures 74, 344 prior to engaging thesuture lock 376 such that an appropriate tension is applied to theleaflet, with the tension subsequently maintained by the ventricularanchor 302. The sutures 74, 344 may remain extending proximally throughthe delivery catheter 100 to a location outside the body. In someembodiments, the proximal ends of the suture 74, 344 may be fed into ahandle or proximal portion of a suture lock delivery system 370 tofacilitate placement of the suture lock and cutting of the sutures 74,344. In some embodiments, the proximal ends may remain free or coupledor secured by other means.

FIG. 11 depicts the advancement of suture lock 376 over the ventricularanchor suture 74 and the leaflet suture 344. The suture lock deliverysubsystem 370 may be advanced through the delivery catheter 100 and atubular pusher catheter 372 may push a suture lock 376 along the distaldirection of the sutures 74, 344. Once the suture lock 376 has reachedthe ventricle, it can continue to be pushed along the ventricle suture74 with proximal traction on the suture 74 and while allowing theleaflet suture 344 to feed distally through the catheter if needed forthe suture lock 376 to advance distally to the ventricular anchor. Asdiscussed further below, FIG. 12 illustrates the final construct withthe leaflet anchor and ventricular anchors tethered together to form anartificial chordae. The proximal tails of the two sutures has beensevered and catheter proximally retracted from the ventricle through themitral valve.

FIGS. 13-14 illustrate various views of the suture lock deliverysubsystem 370 and its components. FIG. 13 depicts a perspective view ofa distal end of the subsystem 370. FIG. 14 depicts a perspective view ofa proximal end of the subsystem 370. FIG. 15 depicts a partiallyexploded view of the distal end of the subsystem 370. FIG. 16 depicts aperspective view of a distal end of a cutting assembly. FIGS. 17 and 18depict side views of a cutting assembly portion of the subsystem 370.FIG. 19 depicts a side view of a suture lock 376 and a distal end of atorque driver 388 configured to engage the suture lock 376. FIGS. 20 and21 depict a proximal end view and a distal end view, respectively, ofthe suture lock 376.

The suture lock delivery subsystem 370 may be configured to advance(e.g., slide) a suture lock 376 over both the sutures 74, 344 (or eventhree or four or additional sutures) securing them together. The sutures74, 344 may each be proximally retracted relative to the suture lock 376to tension the sutures 74, 344 and modulate the length of each suture74, 344 between the suture lock 376 and the respective tissue anchors302, 340. Once the tension and length of the neo chordae implant isoptimized, the suture lock 376 may be locked to fix the length of thesutures 74, 344 such that the sutures 74, 344 can no longer move withrespect to the suture lock 376. The sutures 74, 344 may then be severedat a point proximal to the suture lock 376. The suture 74, 344 may becut by the same suture lock delivery subsystem 370 which delivered thesuture lock 376. In other embodiments, a separate cutting device may beinserted into the delivery catheter 100 after the suture lock has beenlocked in place.

The suture lock allows one or two or more sutures to be advancedtherethrough and adjusted, and then locked with sufficient clampingefficiency that an ePTFE suture can be prevented from slipping from thesuture lock under normal use conditions (e.g., withstand tension of atleast about 60% or 80% or more of the suture breaking strength, withoutslipping). In certain example embodiments, the suture lock allows one ortwo or more sutures to be advanced therethrough and adjusted, and thenlocked with sufficient clamping efficiency that an ePTFE suture can beprevented from slipping from the suture lock under normal use conditions(e.g., withstand tension of at least 60% or 80% or more of the suturebreaking strength, without slipping). The lock may be reopened to permitreadjustment of the tension on the mitral leaflet, and retightened,until a desired result has been achieved. The tightening tool may thenbe removed, leaving the suture lock behind.

The suture lock 376 may be advanced along the sutures by a retainercatheter 373. The distal end of the retainer catheter 373 may be coupledto a retainer element 377 (FIG. 15 ). The retainer element may comprisea flange 371 or other mechanical feature configured to engage the suturelock 376. For example, the flange 371 may be inserted into a recess at aproximal end of the suture lock 376. In some embodiments, rotation ofthe retainer catheter 373 and/or translation substantially perpendicularto the axial direction of the retainer catheter 373 may be used todisengage the retainer catheter 373 from the suture lock 376.

The sutures 74, 344 may extend from their respective tissue anchors topass through the suture lock 376, entering from a distal opening 395 ina distal face of the suture lock 376, shown in FIG. 21 , and exiting ata proximal opening 394 to the suture path in a proximal face of thesuture lock 376, shown in FIG. 20 . The sutures 74, 344 may extendthrough a channel in a cutter head 375 proximal to the suture lock 376and along the outside of the retainer catheter 373 and through thedelivery catheter 100. The cutter head 375 may be coupled to the distalend of a cutter catheter 372. The retainer catheter 373 may extendthrough an internal lumen of the cutter catheter 372 such that the twocatheters 372, 373 may be extendable or retractable relative to oneanother.

Once the sutures 74, 344 are locked (fixedly secured) within the suturelock 376, the proximal ends of the suture 74, 344 may be cut adjacent tothe proximal face of the suture lock. The sutures 74, 344 may be cut byadvancing the cutter catheter 372 coupled to the cutter head 375 towardthe proximal face of the suture lock 376. As schematically illustratedin FIGS. 17-18 , as the cutter head 375 advances along the retainercatheter 373 toward the retainer element 377, the cutter head brings thesutures 74, 344 into close proximity to a cutting blade 379 positionedon the retainer element 377. The cutter head 375 is configured toadvance over the retainer element 377 in such a fashion that the channelin the cutter head 375 retaining the sutures 74, 344 becomesincreasingly spatially occupied by the blade 379. As the blade 379 isforced into the channel of the cutter head 375, the blade 379 shears thesutures 74, 344. Application of proximal tension to the sutures 74, 344may facilitate the cutting of the sutures 74, 344. In other embodiments,different actuations (e.g., rotation of a cutting catheter) can beconfigured to sever the sutures 74, 344.

In some implementations, more than two sutures may be employed and maybe locked within the suture lock 376 and severed by the suture lockdelivery subsystem 370 in the same fashion. In some embodiments,advancement of the cutter head 375 over the retainer element 377 mayfacilitate the disengagement of the retainer catheter 373 from thesuture lock 376. For example, the cutter head 375 may advance to adistal position where it is configured to stabilize the suture lock 376,allowing the retainer catheter 373 to be axially and/or rotationallydisengaged from the suture lock 376.

FIG. 19 illustrates a side view of an example of a suture lock 376(shown with its outer casing/shell removed). The sutures may passthrough the suture lock 376 from a distal end to a proximal end asdescribed elsewhere herein. The suture lock 376 may comprise a screw 382configured to distally advance or proximally retract a push wedge 384,depending on the direction of rotation of the screw. The screw 382 maybe rotated by a torque shaft 388. The torque shaft 388 may comprise adriver head configured to mate with recess 381 (e.g., a polygonal recessor other non-circular shaped recess, as shown in FIG. 20 ) positioned atthe proximal end of the suture lock 376 such that rotation of the torqueshaft 388 causes rotation of the screw 382. The torque shaft 388 mayextend through an internal lumen of the retainer catheter 373. Thetorque shaft 388 may be rotated at its proximal end by a knob 398 orother actuation mechanism positioned at a proximal end of the subsystemhandle 396. The handle 396 may include a hemostasis valve 397. In someimplementations, the sutures 311, 344 may pass through the hemostasisvalve 397.

Advancement of the push wedge 384 by the torque shaft 388 may cause aramp or angled surface 386 to gradually compress one or more springs,such as spring pins 388. The springs bias the clamp upward to open thesuture path until forced closure by rotation of the torque shaft 388.Compression of the one or more springs 388 may force a clamp 390downward on the sutures 311, 344, compressing the sutures 311, 344between two opposing surfaces. In some embodiments, the clamp 390 andthe opposing surface 392 may have notched surfaces configured to matewith each other at discrete increments. The mated notched surfaces mayprovide enhanced friction and, in some implementations, mechanicalinterference for retention of the sutures 311, 344 between the opposingsurfaces such that they cannot be withdrawn, either proximally ordistally, from the suture lock 376. In some embodiments, the tighteningmay be reversible by rotating the torque shaft in an opposite direction.

Once the suture lock is properly positioned over the sutures 74, 344 andlocked into place, the sutures 74, 344 may be severed as describedelsewhere herein. FIG. 12 depicts the retraction of the suture lockdelivery subsystem 370 after the sutures 74, 344 have been cut. Once thesuture lock delivery subsystem 370 has been removed from the deliverycatheter 100, the delivery catheter 100 may be withdrawn from the body.

Collapsible Anchor Delivery Sheath

Depending on the configuration of the anchor assembly 50, coil 54 and/ortubular sleeve 78, in certain embodiments, the outer profile of thedeployed anchor assembly 50 may be larger than the inner diameter of thedelivery catheter 100 and/or introducer sheath. Thus, in certainembodiments, the ventricular anchor delivery subsystem 300 describedabove can be modified as shown in FIGS. 22A-E such that a ventricularanchor delivery subsystem 400 includes a collapsible anchor deliverysheath 404 that can provide protection and support for the anchorassembly 50, coil 54 and/or tubular sleeve 78 during delivery while alsobeing collapsible to fit through the inner diameter of the deliverycatheter 100. In this manner, the collapsible anchor delivery sheath 404can be collapsed to a smaller diameter while the sheath 404 is withdrawninto the delivery catheter 100. Such a collapsible delivery sheath 404can also be configured to secure the anchor assembly 50 during deliverysuch that the anchor assembly 50 will not be stripped out of thedelivery sheath 404 by, for example, the beating ventricle or othermotion or geometries encountered during introduction and placement. Thedelivery sheath 404 may also in certain embodiments be sufficiently kinkresistant to resist movement of the beating ventricle once the coil 54of the anchor assembly 50 is engaged with the heart wall. As will bedescribed below, the sheath 404 can include a radiopaque tip fordetection. The delivery sheath 404 in certain embodiments can have asufficient inner diameter to retain the coil 54 and tubular sleeve 78but small enough in outer diameter to fit within the delivery catheter100 or introducer sheath. In certain embodiments, the anchor deliverysheath 404 is collapsible such that when the anchor assembly 50 isdelivered, the sheath 404 may be drawn through the narrower constrictionof the delivery catheter 100 without excessive force and withouttearing. In certain embodiments, the anchor delivery sheath 404 isadapted to transition in diameter from the size inner diameter of thedelivery catheter 100 (for example, in some embodiments, about 9 Fr) toa second, larger, size required to fit the anchor assembly 50 (forexample, in some embodiments, about 19 Fr). In certain exampleembodiments, the anchor delivery sheath 404 is adapted to transition indiameter from the size inner diameter of the delivery catheter 100 (forexample, in some embodiments, 9 Fr) to a second, larger, size requiredto fit the anchor assembly 50 (for example, in some embodiments, 19 Fr)

In one specific non-limiting, exemplary embodiment of the collapsibleanchor sheath 404, the sheath comprises an approximately 0.005″ wallthermoplastic elastomer material (such as, for example, Pebax)configured into tubes of three different diameters. For example, tworelatively shorter pieces can be used to transition the diameter from asmaller diameter catheter (9 French in an embodiment) to a largerdiameter for accommodating the anchor assembly 50 (19 French diameter inan embodiment). The third tube can form the collapsible portion of thesheath itself. All three pieces can be formed over a tapered mandrelusing a thermal bonding or other suitable forming process. In a furtherembodiment, a radiopaque marker, such as a polymer radiopaque markerband made from, for example, a thermoplastic elastomer with 60% wtTungsten that be incorporated with the sheath and thermally or otherwisesuitably bonded to the sheath.

FIGS. 22A-F illustrate the ventricular anchor delivery subsystem 400with the collapsible sheath 404. The ventricular anchor deliverysubsystem 400 can be used in the methods and steps described above andwith the drive shaft 307, driver head 306 and other components describedabove for rotating and delivering the anchor assembly 50. Theventricular anchor delivery subsystem 400 can include a sheath 405having a proximal portion 410, an intermediate portion 412 and a distalportion 414 that can include the collapsible sheath 404. The proximalportion 410 can include a hemostasis valve 416 with a side port 418. Inthe illustrated embodiment the proximal portion 410 and the intermediateportion 412 of the sheath 405 can be formed from a tube such as astainless steel hypotube which can have an outer diameter of 9 French.The collapsible sheath 404 can be formed form a separate material thatis bonded or otherwise attached to the smaller diameter tube.

As seen in FIGS. 22D and 22E, a distal end of the collapsible sheath 404can have an larger diameter than the intermediate portion 412. FIG. 22Eis a longitudinal cross-sectional view of FIG. 22D. Threads 422 can beformed on the inner surface of the distal end of the collapsible sheath404 to retain the anchor assembly 50 within collapsible sheath 404.Thus, in one arrangement, the coil 54 of the anchor assembly 50 canengage the threads 422 in the collapsible sheath 404 such that theanchor assembly 50 is retained within the sheath 404. Rotation of theanchor assembly 50 can drive the anchor assembly 50 forward through thesheath 404. In this manner, the sheath 404 can support the anchorassembly 50 during delivery such that the anchor assembly 50 will not bestripped out of the delivery sheath 404 during delivery. The distallarger diameter end of the sheath 404 is also collapsible to fit throughthe inner diameter of the delivery catheter 100 such that thecollapsible anchor delivery sheath 404 can be withdrawn into thedelivery catheter 100. In modified arrangements, the sheath 404 caninclude grooves, protrusions or other elements for engaging the anchorassembly 50.

In general, the sheath 404 may be provided with any of a variety ofinterference elements which releasably engage an implantable device suchas a helical tissue anchor and resist axial pull out of the helicalanchor once positioned within the sheath. Rotation of the anchor in afirst direction relative to the sheath causes the anchor to move axiallydistally as the helix unthreads from the sheath. The interferenceelement may be a helical (radially outwardly extending) channel or(radially inwardly extending) ridge, extending at least about one or twoor four or more complete revolutions about the inner circumference ofthe sheath. In certain example embodiments, the interference element maybe a helical (radially outwardly extending) channel or (radiallyinwardly extending) ridge, extending at least one or two or four or morecomplete revolutions about or around the inner circumference of thesheath.

Alternatively, at least about one or two or six or more radiallyinwardly extending tabs may be provided, each extending less than a fullrevolution around the circumference of the sheath. In certain exampleembodiments, at least one or two or six or more radially inwardlyextending tabs may be provided, each extending less than a fullrevolution around the circumference of the sheath. Engagement tabs mayhave a length in the circumferential direction of no more than about 90degrees, and in some implementations no more than about 45 degrees or 20degrees or 10 degrees or less around the inside surface of the sheath.In certain example embodiments, engagement tabs may have a length in thecircumferential direction of no more than 90 degrees, and in someimplementations no more than 45 degrees or 20 degrees or 10 degrees orless around the inside surface of the sheath. Depending upon the desiredperformance, the implant can be disengaged from the catheter by aplurality of complete rotations, or by a rotation through, for example,less than a full rotation such as less than about a half or a quarterturn relative to the catheter. In certain example embodiments, dependingupon the desired performance, the implant can be disengaged from thecatheter by a plurality of complete rotations, or by a rotation through,for example, less than a full rotation such as less than a half or aquarter turn relative to the catheter.

Either the catheter side wall, the rotational anchor driver or both maybe provided with torque transmission elements such as a spiral wound orbraided side wall to facilitate rotation of the driver and inhibitrotation of the deployment catheter.

The sheath extends between a distal open end and a proximal end attachedto the catheter shaft. The proximal end may have an angled engagementsurface, for slidably engaging the distal opening on a delivery catheterso that the sheath is transformable from the radially enlargedconfiguration to the radially reduced configuration in response toproximal retraction into the delivery catheter.

The sheath may have an axial length that corresponds to the intendedimplant, generally less than about 15 cm and in many implementations nomore than about 10 cm or 5 cm or 3 cm or less. In certain exampleembodiments, the sheath may have an axial length that corresponds to theintended implant, generally less than 15 cm and in many implementationsno more than 10 cm or 5 cm or 3 cm or less.

The rotational interlock feature described above can be implemented onthe inside surface of a flexible (collapsible) sidewall as describedabove, or on a fixed (non collapsible) sidewall catheter, in anembodiment where the OD of the device is smaller than the ID of thelumen in the deployment catheter. In a collapsible sheathimplementation, the sheath may be collapsed following deployment of thedevice, by proximal retraction into the delivery catheter, which mayhave an ID which is smaller than the OD of the sheath when in theradially enlarged configuration for containing the implantable device.

FIG. 22F illustrates a method of forming the collapsible sheath 404. Amandrel 426 having a first diameter 430 and a second smaller diameter432 can be provided. FIG. 22F is a longitudinal cross-sectional view ofthe mandrel similar to the cross-section view of FIG. 2E. The smalldiameter portion 432 of the mandrel 426 can be positioned within distalend of the intermediate portion 412. The mandrel 426 can include atransition zone 427 between the first and second portions 430 and 432 ofthe mandrel 426. A coil 450 can be positioned on an outer surface of thelarger diameter portion 430 of the mandrel 426. A sheath 452 which willform the collapsible sheath 404 can be positioned over the mandrel 426and the distal end of the tube intermediate portion 412. In anembodiment, the sheath 452 can comprise an approximately 0.005″ wallthermoplastic elastomer (such as Pebax). The sheath 452 can be heattreated while on the mandrel 426 such that the proximal end of thesheath 452 is reduced in diameter and bonded to intermediate portion 412and the distal end of the sheath 452 takes on the form of the coil 450to form internal threads on the sheath 404. As noted above, the sheath404 can include a radiopaque marker, such as a polymer radiopaque markerband made from, for example, a thermoplastic elastomer with 60% wtTungsten that be incorporated with the sheath and thermally or otherwisesuitably bonded to the sheath 404. In an embodiment, the marker ispositioned on a distal end of the sheath.

FIG. 22G illustrates a side view of a steering zone near a distal end ofthe delivery catheter 100 that can be articulated or bent in a firstdirection with respect to a central axis of the delivery catheter 100.The delivery catheter 100, as described herein, can be used to deliver avariety of subsystems. As such, the delivery catheter 100 can beconfigured to be positioned in the left atrium (such as shown in FIG.3-6A) or the left ventricle (such as shown in FIG. 1 ). To achieve thisposition, the delivery catheter 100 can include a steering zone or firstbend 102 such that the distal portion 108 of the catheter 100 is angledaway from the proximal portion 106 of the catheter 100. In this manner,the steering zone of the delivery catheter 100 can be activelydeflectable to form a delivery catheter curve that resides in a deliverycatheter curve plane (also referred to herein as a first plane or X-Yplane). As shown in FIG. 22G, the delivery catheter 100 can bend in arange of angles. For example, the delivery catheter 100 can bearticulated to include the first bend 102 such that the longitudinalcentral axis of a portion of the delivery catheter 100 distal to thebend forms an angle A with respect to a longitudinal central axis of aportion of the delivery catheter proximal to the bend 102. The angle Acan be between 10 to 150 degrees and in certain embodiments the angle Acan be between 30 and 80 degrees and in certain embodiments between 35and 70 degrees. In some examples, the first bend 102 may be gradual suchthat the radius of curvature is at least 0.9 inches. In some examples,the first bend 102 can have a radius of curvature between 0.5 to 1.0inches. The delivery catheter 100 can include various device andmechanisms for articulating the steering zone such as, for example,various combinations of pull wires that can be used to steer thecatheter 100.

FIG. 22H is a perspective view of an embodiment of the ventricularanchor delivery sheath 700 that can include an elongate, flexibletubular body having a proximal end, a distal end, and a longitudinalaxis. The ventricular anchor delivery sheath 700 can include a proximalpreset curve 702 and a distal preset curve 704 and can be axiallyadvanced through the delivery catheter 100. An access system can includethe delivery catheter 100 and ventricular anchor sheath 700 fordirecting a ventricular anchor sheath at a target site in a leftventricle. The ventricular anchor sheath 700 can have a proximal portion706, an intermediate portion 708 and a distal portion 710. As shown, theventricular anchor sheath 700 can include a collapsible sheath 404 atthe distal end of the distal portion 710 which can be configured asdescribed above with the distal end of the collapsible sheath 404forming a distal end of the ventricular anchor sheath 700. Thecollapsible sheath 404 can be a distal anchor compartment having acollapsible side wall. The proximal preset curve 702 can be positionedbetween the proximal portion 706 and the intermediate portion 708. Thedistal preset curve 704 can be positioned between the intermediateportion 708 and the distal portion 710. The ventricular anchor sheath700 can be pre-formed or preset with the proximal preset curve 702 andthe distal preset curve 704 such that the ventricular anchor sheath 700takes on the form illustrated in FIG. 22H when it is unconstrained by anouter sheath such as the delivery sheath 100 discussed above. Theproximal preset curve 702 can be proximal to the distal preset curve704. The distal preset curve 704 can be distal to the proximal presetcurve 702. In certain embodiments, the ventricular anchor sheath 700 isheat set into the shape shown in FIG. 22H to form the proximal anddistal preset curves 702, 704 by placing the vertical anchor sheath 700over a mandrel with the desired shape and then heat treating the sheath700 to apply a pre-formed shape to the sheath 700. In some examples, theventricular anchor sheath 700 can be shaped by applying heat andmanually bending the ventricular anchor sheath 700 around a fixture toachieve the desired geometry. In other examples, the ventricular anchorsheath 700 can also be shaped by loading the ventricular anchor sheath700 into a cassette with a preset geometry and applying heat to set theventricular anchor sheath 700 in the desired geometry.

The proximal preset curve 702 of the ventricular anchor sheath 700 canbe bent within the proximal preset curve plane (also referred to as theX-Y plane or first plane) to produce a range of angles B between acentral longitudinal axis 705 of the proximal portion 706 and a centrallongitudinal axis 715 of the intermediate portion 708. For example, theangle B can be between 70 to 100 degrees and in certain embodiments canbe between 85 and 95 degrees and in certain embodiments can be 90degrees. In some examples, the proximal preset curve 702 may be gradualsuch that the radius of curvature is 2.0 inches. In some examples, theproximal preset curve 702 can have a radius of curvature between 0.5 to3.0 inches. As will be explained below, the proximal preset curve 702can help or orientate the ventricular sheath 700 within the deliverycatheter 100. For example, the proximal preset curve 702 can have radiuscorresponding or similar to the radius of the first bend 102 of thedelivery catheter 100. Accordingly as the ventricular sheath 700 isadvanced through the delivery catheter 100, the proximal preset curve702 causes the ventricular sheath 700 to take a specific rotationalorientation within the delivery catheter 100 such that as a distalportion 710 of the ventricular sheath 700 exists the delivery catheter100 it exists at a specific rotational orientation. Accordingly, thedistal portion 710 of the ventricular sheath 700 can be pointed in aspecific direction as it exists the delivery catheter 100. If theventricle sheath 700 is not in the correct rotational orientation, theuser can receive tactile feedback in the form of resistance to axialadvancement of the sheath 700 through the delivery catheter 100.Rotation of the sheath 700 into the proper rotational orientation willreduce this resistance providing feedback to the use that the sheath 700is correctly orientated. As shown in FIG. 22H, the proximal preset curve702 can reside in the first plane 725 which can be referred to herein asa X-Y plane or the proximal preset curve plane 725.

As shown in FIG. 22H, the ventricular anchor sheath 700 can be bent sothat portions of the sheath 700 can extend in two different planes. Theproximal portion 706, proximal preset curve 702, and the intermediateportion 708 can be within the first plane 725, which can be referred asthe X-Z plane or proximal preset curve plane as noted above. A y-axiscan be perpendicular to the first plane 725 as shown in FIG. 22H. Acentral longitudinal axis 720 of the distal portion 710 can be withinthe second plane 730. The proximal preset curve 702 can angle theintermediate portion 708 away from the proximal portion 706 within thefirst plane 725 as described. The distal preset curve 704, in turn, canangle the distal portion 710 away from the intermediate portion 708 intothe second plane 730 which can also be referred to as the distal presetcurve plane or second plane. The distal preset curve 704 of theventricular anchor sheath 700 can form an angle defined between thecentral longitudinal axis 715 of the intermediate portion 708 and thecentral longitudinal axis 720 of the distal portion 710. The anglebetween the central longitudinal axis 715 of the intermediate portion708 and the central longitudinal axis 720 of the distal portion 710 canhave two components: an angle α within the X-Z plane and shown in FIG.22I and an angle (3 in the Z-Y plane shown in FIG. 22J such that thatthe distal portion 710 lies in a different plane than the intermediate708 and proximal portion 710 of the sheath 800 and which is angled withrespect to the X-Y plane. The intermediate portion 708 can have a lengthbetween 20 mm to 50 mm, such as approximately 32 mm, and the distalportion 710 can have a length between 20 mm to 50 mm, such asapproximately 31 mm The length of the intermediate portion 708 can beused to control the ventricular implant location in the ventricle suchthat in certain embodiments the ventricular implant can be positioned atthe base of the papillaries. The length of the distal portion 710 can beused to control distance from the centerline of the heart to the wall ofthe heart. As explained below, the intermediate portion 708 can centerthe distal portion 710 of the ventricle sheath over the mitral valve.The distal preset curve 704 can direct the distal portion 710 of thesheath 700 from above the mitral valve to a position through the mitralvalve and towards the ventricle such that a ventricular anchor asdescribed above can be placed.

In the illustrated embodiment, the distance between the distal end ofthe ventricular anchor sheath 700 and a longitudinal center or mid-pointof the distal preset curve 704 can be within the range of 30 to 90millimeters in an embodiment and within the range of 50 to 70millimeters in another embodiment and about 60 millimeters in anotherembodiment. In certain example embodiments, the distance between thedistal end of the ventricular anchor sheath 700 and a longitudinalcenter or mid-point of the distal preset curve 704 can be within therange of 30 to 90 millimeters in an embodiment and within the range of50 to 70 millimeters in another embodiment and 60 millimeters in anotherembodiment. In the illustrated embodiment, the distance between thedistal end of the ventricular anchor sheath 700 and a longitudinalcenter or mid-point of the proximal preset curve 702 can be within therange of 80 to 165 millimeters in an embodiment and within the range of100 to 145 millimeters in another embodiment and about 125 millimetersin another embodiment. In certain example embodiments, the distancebetween the distal end of the ventricular anchor sheath 700 and alongitudinal center or mid-point of the proximal preset curve 702 can bewithin the range of 80 to 165 millimeters in an embodiment and withinthe range of 100 to 145 millimeters in another embodiment and 125millimeters in another embodiment. In the illustrated embodiment, thedistance a longitudinal center or mid-point of the distal preset curve704 and a longitudinal center or mid-point of the proximal preset curve702 can be within the range of 45 to 85 millimeters in an embodiment andwithin the range of 25 to 105 millimeters in another embodiment andabout 65 millimeters in another embodiment. In certain exampleembodiments, the distance a longitudinal center or mid-point of thedistal preset curve 704 and a longitudinal center or mid-point of theproximal preset curve 702 can be within the range of 45 to 85millimeters in an embodiment and within the range of 25 to 105millimeters in another embodiment and 65 millimeters in anotherembodiment.

FIG. 22I is a top view of the ventricular anchor sheath 700 of FIGS.22H-I to illustrate the angle, a in the X-Z plane. As shown in FIG. 22I,the distal portion 710 can incline at an angle, a, within a range of 5degrees to 60 degrees with respect to the central longitudinal axis ofthe intermediate portion 708 in the X-Z plane. For example, the angle αof the distal preset curve 704 can be approximately 45 degrees in thewith respect to the central longitudinal axis of the intermediateportion 708 in the X-Z plane.

FIG. 22J is a side view of the ventricular anchor sheath 700 of FIGS.22H-I. As shown in FIG. 22J, the central longitudinal axis 720 of thedistal portion 710 can be inclined at the angle, β with respect to thecentral longitudinal axis 705 of the proximal portion 706 or the Z-axisin the X-Z plane described above and the angle β can be within a rangeof 40 to 75 degrees. For example, the angle β formed by the distalpreset curve 704 can be approximately 40 to 75 degrees in the ydirection measured from the z-axis, which can be substantially parallelto the central longitudinal axis 705 of the proximal portion 706. Incertain embodiments, the angle β can be 60 degrees. Accordingly, in theillustrated embodiment distal preset curve 704 can reside in a secondplane also referred to herein as a distal preset curve plane thatrotationally offset from the first plane (i.e. the X-Z plane or proximalpreset curve plane) by an angle within the range of from 40 to 75degrees and in certain embodiments 60 degrees.

FIG. 22K is a front view of the ventricular anchor sheath 700 of FIGS.22H-J. As shown in FIG. 22K, the distal portion 710 can incline at anangle, θ, in the x direction measured from the y-axis. For example, theangle θ of the distal preset curve 704 can be approximately 30 to 60degrees and in some embodiments 45 degrees in the x direction measuredfrom the y-axis, which can be substantially perpendicular to thelongitudinal axis 705 of the proximal portion 706.

In some examples, the distal preset curve 704 may be sharper than theproximal preset curve 702. For example, the distal preset curve 704 canhave a radius of curvature of 0.45 inches. In some examples, the distalpreset curve 704 can have a radius of curvature between 0.1 to 0.5inches. In certain embodiments, an arc length of the distal preset curveis no more than about 50% of the arc length of the proximal preset curveand in certain embodiments, the arc length of the distal preset curve isno more than about 20% of the arc length of the proximal preset curve.In certain example embodiments, an arc length of the distal preset curveis no more than 50% of the arc length of the proximal preset curve andin certain embodiments, the arc length of the distal preset curve is nomore than 20% of the arc length of the proximal preset curve.

FIG. 22L illustrates placement of a ventricular anchor 302 with theventricular anchor sheath 700 of FIGS. 22H-K and the delivery sheath ofFIG. 22G. The ventricular anchor sheath 700 can be used in the methodsand steps described above (such as with the drive shaft 307, driver head306 and other components described above for rotating and delivering theanchor assembly 50). For example, the ventricular anchor delivery sheath700 can be inserted and pass through the catheter 100. The ventricularanchor delivery sheath 700 can deliver a ventricular anchor, such as ahelical anchor 32.

The ventricular anchor sheath 700 can be advanced through the deliverycatheter 100. When the ventricular anchor sheath 700 is fully insertedwithin the delivery catheter 100 such that the intermediate portion 708and distal portion 710 are advanced out of the delivery catheter 100,the proximal preset curve 702 of the ventricular anchor sheath 700 canbe aligned with the first bend 102 and delivery catheter curve of thedelivery catheter 100. The proximal portion 106 of the delivery catheter100 can be aligned with the proximal portion 706 of the ventricularanchor sheath 700. The intermediate portion 708 and the distal portion710 of the ventricular anchor sheath 700 can extend beyond the distalportion 106 of the delivery catheter 100 as shown in FIG. 22L. Thealignment of the first bend 102 of the delivery catheter 100 and theproximal preset curve 702 of the ventricular anchor sheath 700 caninsure that the distal portion 710 of the ventricular anchor sheath 700is oriented correctly when it exits the delivery catheter 100. Forexample, the delivery catheter 100 can have a first bend 102 in adelivery catheter curve to position and orient the distal portion 108within the ventricular atrium. The ventricular anchor sheath 700 can bepositioned within the delivery catheter 100 such that distal portion 710of the ventricular anchor sheath 700 extends from the distal end of thedelivery catheter 100 and is positioned in the left ventricle. Theanchor sheath 700 is configured to rotate within the delivery catheter100 to bias the proximal preset curve plane into alignment with thedelivery catheter curve plane in response to axial alignment of theanchor sheath proximal preset curve within the delivery catheter curve.In certain embodiments, the proximal preset curve 702 and the deliverycatheter curve 102 are configured to cooperate to provide tactileindicium of the rotational alignment of the anchor sheath 700 within thedelivery catheter 100.

The ventricular anchor sheath 700 can be positioned such that theproximal preset curve 702 orients the intermediate portion 708 partiallyin the left atrium and across the valve and the distal preset curve 704orients the distal portion 710 in the left ventricle. The deliverycatheter 100 would be positioned in the left atrium, such as shown inFIGS. 11 and 12 and FIG. 22L. The ventricular anchor sheath 700 can bepositioned within the delivery catheter 100 such that the first bend 102of the delivery catheter 100 is aligned with the proximal preset curve702 of the ventricular anchor sheath 700. The ventricular anchor, suchas ventricular anchor 32, can then be inserted through the ventricularanchor sheath 700 for delivery. For example, the ventricular anchor 302can be delivered to into heart tissue, e.g., near the apex of the leftventricle or near a papillary muscle.

The proximal preset curve 702 and the distal preset curve 704 of theventricular anchor sheath 700 can be preset. As noted above, in someexamples, the ventricular anchor sheath 700 can be made with a curvedmandrel to heat set the angles of the bends of the ventricular anchorsheath 700. The ventricular anchor sheath 700 can be substantiallyflexible and bendable such that when the ventricular anchor sheath 700is being inserted into the delivery catheter 100, the ventricular anchorsheath 700 can be substantially aligned with the delivery catheter 100.For example, if the delivery catheter 100 was substantially straight,the ventricular anchor sheath 700 can be substantially straight whenpositioned within the delivery catheter 100. When the distal presetcurve 704 and the distal portion 710 is exposed and not constrainedwithin the delivery catheter 100, the preset curve of the proximalpreset curve 702 is aligned with the bend 102 of the delivery catheter100 would orient the proximal preset curve 704 and the preset curve ofthe second bend 704 would orient the distal portion 710 in the desiredorientation within the heart. The ventricular anchor sheath 700 caninclude a distal marker near the second bend 704 to indicate how far theinner ventricular anchor sheath 700 to be extended beyond the deliverycatheter 100. An advantage of the two preset curves (proximal anddistal) in the anchor catheter sheath 700 described herein is such thatwhen the delivery catheter 100 is positioned centrally above the mitralvalve in the atrium, simply advancing the anchor catheter sheath 700distally from the end of the delivery catheter 100 will direct the tipof the anchor catheter sheath 700 to a target location, which can bebetween the base of the papillary muscles on the posterior leftventricle wall without any additional catheter manipulation.

As noted above, the above described embodiment with preset proximal anddistal curves 702 and 704 can advantageously direct the distal end ofthe anchor sheath to a desired location for the anchor as the anchorsheath exits the delivery catheter. In a modified embodiment, the anchorsheath 700 can be steerable through the use of pull wires or othermechanisms for steering a catheter. In such embodiments, the steerableanchor sheath 700 can be configured to have proximal and distal steeringzones that can be configured at the locations described above and canarticulate through the angles described above for the preset proximaland distal curves 702, 704. In another embodiment, a present mandrel canbe provided with preset proximal and distal curves 702, 704 arranged asdescribed above. The preset mandrel can then be inserted through anchorsheath so that the anchor sheath takes on the shape of the presetmandrel.

Rotational Suture Cutter

FIGS. 23A-C, 24A-D, 25A-B and 26 illustrate another embodiment of acutter catheter 500 that can be used to cut sutures 74, 344 in one moreof the procedures and systems described above. For example, once thesutures 74, 344 are locked (fixedly secured) within the suture lock 376,the proximal ends of the sutures 74, 344 may be cut adjacent to theproximal face of the suture lock 376 with an embodiment of the suturecutter catheter 500 described herein.

With initial reference to FIGS. 23A and 23B, the cutter catheter (alsoreferred to as a endovascular suture cutter) 500 can include an outersheath 504 extending through the delivery catheter 502 and an innershaft 506 extending through the outer sheath 504. A proximal end of theouter sheath 504 can be coupled to a luer lock 503. With reference toFIG. 24 , the outer sheath 504 is coupled to a cutter housing 510 at thedistal end of the outer sheath 504. The cutter housing 510 can be in theshape of a barrel that forms cylindrical chamber. The distal end of thecutter housing 510 can have opening 512 through which sutures can extendfrom the opening 512 and then through a window 514 formed on a side ofthe cutter housing 510 to define a suture path extending through thecutter housing 510. In this manner, sutures 74, 344 can be advancedthrough the cutter housing 510 as shown in FIG. 23C.

With reference to FIGS. 25A, 25B and 26 , a cutter head 520 can berotationally positioned within the cutter housing 510. The cutter head520 can have a hollow half-barrel or partial barrel shape that includesa cutting edge 522. The cutting edge 522 can have a helical path orcurved shape as the edge 522 extends from the distal end to the proximalend of the cutter head 520. The cutting edge 522 can extend along a sidesurface of the cutter head 520 as shown in FIG. 26 . Sutures extendingthrough the distal opening 512 and the side window 514 can be cut byrotating the cutter head 520 within the cutter housing 510. Rotationwill cause the sutures to be compressed between the cutting edge 522 andthe inside surface of the cutter housing 510. Because of the profile ofthe cutting edge 522, the sutures can be sliced which can produce a moreefficient and reliable cutting motion as compared to compressing orchopping motions.

Advantageously, when the endovascular suture cutter 500 is advanced intothe heart the cutting edge 522 of the cutter head 520 is not exposed andcovered by the surfaces of cutter housing 510. For example, as shown inFIG. 26 , the cutting edge 522 is covered by the inside surfaces of thecutter housing 510. In the illustrated embodiment, the cutter catheter500 also includes a lock 540 at the distal end of the endovascularsuture cutter 500 to prevent rotation between the cutter head 520 andthe cutter housing 510. In the illustrated embodiment, the lock 540 cancomprise a protrusion 550 on the cutter head 520 that engages acorresponding recess 552 in the cutter housing 510. When engaged, theprotrusion 550 and the recess 552 prevent rotation between the cutterhead 520 and the cutter housing 510. In this manner, the cutting edges522 can remain in a position in which they are not exposed and arecovered by the inner surfaces of the cutter housing 510. The protrusion520 and the recess 522 can be disengaged by axially advancing therotational housing 520 with respect to the cutter housing 510. In thedisengaged positon, the cutter head 520 can be rotated with respect tothe cutter housing 510 to cut sutures as described above. The protrusion520 and the recess 522 can be reversed in other arrangements and/orpositioned on other portions of the cutter housing 510 and cutter head520.

FIG. 27 illustrates a proximal handle 570 which can be formed around theluer lock 503. The handle 570 can be used to control the movement of thecutter head 520 and cutter housing 510. In this arrangement, the cutterhead 510 can be fixed with respect to a handle 570. The cutter head 520can be rotationally linked and coupled to a suture cutter handle 572such that rotation of the suture cutter handle 572 will cause the cutterhead 520 to rotate with respect to the cutter housing 510. As shown, thesuture cutter handle 572 is positioned in retracted position withrespect to the handle 570 in which the protrusion 550 and the recess 552would be engaged to prevent rotation between the cutter head 520 and thecutter housing 510. A lock 578 can be provided on the handle 570.Releasing the lock 578, allows the cutter head handle 572 to moveaxially (e.g., distally in the illustrated embodiment) with respect tothe handle 570. In this manner, the protrusion 550 and the recess 552can be disengaged and the suture cutter handle 572 can be rotated withrespect to the handle 570 to cut sutures.

Pledget with Radiopaque Marker

FIGS. 28-31 illustrate an embodiment of a leaflet anchor 641 that caninclude a pledget 640 and can be use used with and in the systems andmethods described herein. FIGS. 28 and 29 schematically depict anembodiment the pledget 640 that formed by affixing a distal end a suture644 between two flat sheets 645 a, 645 b. FIG. 29 shows a cross-sectionof the pledget 640 along the axis of B-B illustrated in FIG. 28 . Insome embodiments, the suture 644 may be inserted between the two sheets645 a, 645 b (e.g., substantially down the middle of the sheets) andpressed and/or laminated to join the three components together (e.g.,under heat and/or pressure). At least one of the layers may be partiallysintered. The suture 644 may be flattened and/or densified to improveresistance to suture tear out. The sheets may be flatpolytetrafluoroethylene (PTFE) sheets (e.g., thin uncured expanded PTFE(ePTFE) sheets) or any other suitable material. In some implementations,the leaflet suture 644 may be disposed between the sheets in alternativeconfigurations, such as a zig-zag or s-shaped configuration. FIG. 30shows the pledget 640 of FIG. 28 comprising a plurality of apertures 643through which a proximal tail end 660 of the suture 644 may be threadedthrough. In some embodiments, one or more apertures 643 may be formedthrough the pledget, in various configurations, to form a collapsiblestructure, as described elsewhere herein, which is configured to anchorthe suture 644 against the mitral leaflet. FIG. 30 shows apertures 643extending through the center of the pledget through the suture 644. Insome embodiments, the apertures 643 can be alternating around opposingsides of the suture 644. In some embodiments, the apertures 643 may beformed on the same side of the suture 644 (e.g., in wing 641 or wing642). In the illustrated arrangement, the apertures 643 can be formedthrough the suture 644. The apertures 643 can be aligned along a centerof the pledget 640. The apertures 643 may be aligned along the length ofthe suture 644 (e.g., may form a straight line). The apertures 643 canextend from a first or proximal end to a distal or second end of thepledget 640. The suture 644 may be at least partially flattened betweenthe two opposing sheets, which may facilitate the placement of apertures643 through the suture 644. Various combinations of apertures 643,including the positioning described above, may be used.

A radiopaque marker may be added to the pledget 640. For example, in theillustrated embodiment of FIGS. 28-31 , a marker band 660 a can bepositioned about or around the suture adjacent the second or distal endof the pledget 640. The marker band 660 a can be crimped to the suture644 in this position. The proximal end 660 of the suture 644 can then bethreaded through the apertures 643 formed in the pledget 640 startingwith an aperture 643 closest to the marker band 660 a as shown in FIG.31 thereby positioning the marker band 660 a at the distal end of thepledget 640 when deployed. The pledget 640 may be transformable from anelongate strip configuration to a radially enlarged, axially shortenedconfiguration by proximal retraction of the suture 644.

Flexible Pledget Delivery Needle

As noted above, in certain embodiments, a radially enlargeable leafletanchor may be carried within a hollow needle having a sharpened end forpiercing the leaflet. The radially enlargeable leaflet anchor maycomprise a pledget. The pledget may be transformable from an elongatestrip configuration to a radially enlarged, axially shortenedconfiguration by proximal retraction of the suture.

In some embodiments, the hollow needle comprises an exterior surfacehaving one or more helical grooves. In other embodiments, the hollowneedle may comprise one or more raised helical coils, for example, athin coil that is attached to the exterior of the hollow needle. FIG. 32shows an embodiment wherein the hollow needle 1204 has a helical coil1205 attached to an outer surface of the needle 1204. Since the leafletmay be in motion before, during and after the puncture process, theleaflet may have enough range of motion that a hollow needle withoutgrooves or the raised helical coil may slip off of the leaflet. Thegrooved surface or raised helical coil can present several benefits.First, in the event that the hollow needle does not completely puncturethe leaflet, i.e., the distal portion of the hollow needle does notallow delivery of the pledget or if the physician determines that thehollow needle may prematurely slip off of the leaflet during theprocedure, the physician can provide a force onto the catheter or amechanism within the catheter that transfers a rotational force to theneedle, thereby screwing the hollow needle in further to the leaflettissue and securing leaflet so that it does not move off of the needle.Secondly, once the pledget has been delivered, the physician can providea force to the catheter or a mechanism within the catheter thattransfers a rotation force to the hollow needle, thereby allowing thephysician to remove the needle by unscrewing the hollow needle from theleaflet.

According to the catheter system used, the hollow needle can be directedto puncture the needle from the left atrial side of the heart to theleft ventricular side. In other embodiments, the hollow needle can bedirected to puncture the leaflet from the left ventricular side of theheart to the left atrial side. Since the entry points from the exteriorof the patient to the heart can vary, it can be desirable that at leasta portion of the hollow needle is flexible. Utilizing a flexible hollowneedle can allow the hollow needle to travel around all of the curvaturein order to access the leaflet and can allow the physician the abilityto fine tune placement of the needle prior to puncturing the leaflet.FIG. 32 shows cut portions 1203 of the hollow needle which allow thehollow needle to flex as needed. In some embodiments, the cut portions1203, of the hollow needle can be laser cut, can be machined, or otherknown methods can be used.

The system can also comprise a hollow needle wherein the hollow needlepunctures the leaflet via the release of a stored energy source. Forexample, the stored energy can be in the form of a spring, a liquidunder pressure, a gas under pressure, an electrically activated pistonor other known method. In some embodiments, the stored energy device isa spring. In still further embodiments, the spring is located in thepledget delivery handle 1202, shown in FIG. 33 .

The amount of stored energy should provide enough force to the hollowneedle in order to puncture the leaflet a sufficient distance or depth.As used herein, “sufficient distance or depth” can mean one or more ofthe following: wherein the distal end of the hollow needle completelypunctures the leaflet without causing the hollow needle to contact orpuncture any other structures within the heart; allows the needle tostay engaged with the leaflet while the leaflet is moving; and allowsthe physician to deliver the pledget. If the needle did not puncturethrough the leaflet a sufficient distance or depth, the physician canrotate the hollow needle in order to drive the hollow needle furtherthrough the leaflet tissue. If the needle did not puncture the leafletin the correct location, the physician can rotate the hollow needle inan opposite direction thereby removing the hollow needle from theleaflet tissue. The system can then be re-armed, that is, re-energizedwith the stored energy, repositioned and actuated in order to properlyplace the hollow needle for delivery of the pledget. In someembodiments, the system comprises a control device wherein the physicianis able to position the catheter (containing the retracted hollowneedle) on or near the leaflet, check the positioning of the catheterrelative to the leaflet to be sure that the catheter is in the correctlocation and actuate the release of the stored energy to puncture theleaflet. At least a portion of the distal end of the catheter, of thehollow needle or both may be radiopaque or include other visualizationaids in order to allow the physician to check that the position of thepuncture is correct prior to delivering the pledget, via the release ofthe stored energy.

Component Stabilization and Suture Management System

An aspect of the present disclosure that can be used alone or incombination with aspects of the disclosure described above is astabilization system for a transvascular cardiac repair that can be usedto stabilize and/or adjust the position of a proximal portion (e.g., ahandle) of one or more of the subassembly components described (e.g.,the delivery catheter 100 and/or one or more of the various subsystemsthat can be advanced into the delivery catheter). The stabilizationsystem can also include a suture management system for adjusting thelength and/or the tension on one or both of the ventricular anchorsuture and at least one leaflet suture.

In certain aspects, the suture management system for transvascularcardiac repair can assist in maintaining a substantially fixed force, ortension, on the sutures while the physician is adjusting the suturelengths and setting the tension of the suture lock. It should beunderstood by one of skill in the art that the term “substantially fixedforce” may include allowing for some small changes in tension to occur.For example, in one aspect a 10% change in tension can occur.

An advantage of using such a suture management system is that theleaflet can be allowed to continue moving during the repair procedure inits “natural” state in response to the beating of the heart, but eachpledget can be maintained substantially in contact with the leafletthrough application of substantially constant tension on the sutures.Additionally, suture tangling can be prevented or minimized through useof the apparatus. A further advantage is that the physician canindividually adjust each suture for decreasing or increasing tension totailor the final movement of the leaflet, as appropriate. The suturemanagement system can be located in the operating room near thephysician during surgery. After the anchor and leaflet sutures aredeployed in the patient, the ends of the sutures that pass through thedelivery catheter can be attached to the suture management system andheld in the aforementioned substantially constant tension.

In certain aspects of the disclosure, aspects of the stabilizationsystem can have advantages and be used independently and without aspectsof the suture management system or device. In a similar manner, incertain aspects of the suture management system can have advantages andcan be used independently and without aspects of the stabilizationsystem. Nevertheless, as described herein, certain advantages can beachieved system utilizing combinations and sub-combinations variousaspects of the stabilization and suture management systems describedherein.

FIGS. 34A and 34B illustrate an embodiment of a stabilization system(also referred to herein as “system”) 1500. The system 1500 cancomprises a base, or tray, 1502 which can be mounted to a stand or table(not shown) to avoid movement of the apparatus during a procedure. Asshown in FIG. 35 , the base can comprise an upper or top plate 1504 anda lower or bottom plate 1506. The upper and lower plates (also referredto herein as top and bottom plates) 1504, 1506 can be moveably connectedto each other through an adjustable positioning mechanism 1510 (alsoreferred to herein as “adjustment mechanism”), which in the illustratedembodiment can comprise a lower threaded boss 1512 that is coupled to athe lower plate 1506 and an upper threaded boss 1514 that is coupled tothe upper plate 1504. A screw 1516 can extend through the lower andupper threaded bosses 1512, 1514. Axial motion of the screw 1516 (seeFIG. 35 ) with respect to the lower plate 1506 can be limited such thatrotation of a screw handle 1518 can cause the upper plate 1504 to movewith respect to the lower plate 1506. In this manner, the adjustmentmechanism 1510 can re-position in the upper plate 1504 (and componentscoupled thereto) with respect the direction of arrow 1520 to the lowerplate 1506, which can be attached to the stand or table, as needed. Theadjustment mechanism 1510 can include a lock to prevent movement betweenthe upper and lower plates 1504, 1506. In several embodiments, othermechanisms can be used to similarly move the upper and lower platesreciprocally in axial direction with respect to each other such assliding plates, complimentary rail and second channel or rollers.

A stabilization portion 1550 of the system 1500 can include severalcomponents that can be used to hold or stabilize components of themitral valve chord repair devices described above. In particular, aswill be described in detail below, the device can be used to hold orstabilize a proximal portion (e.g., a handle) of an introducer sheath, adelivery catheter 100, ventricular anchor delivery subsystem 300, asuture lock delivery subsystem 370, a pledget delivery subsystem orhandle 1202, and/or proximal end or handle of a suture cutter catheter500 and such components can be configured in accordance with theembodiments and aspects describe herein.

For example, the system can include a first docking platform 1600 thatcan be positioned on a distal portion of the system 1500 and can bereferred to herein as the “distal docking platform 1600”. The distaldocking platform 1600 can be configured to hold or stabilize a handle orproximal portion of an introducer catheter through which variouscomponents of the delivery subsystems described herein can be advanced.With reference to FIG. 35 , the distal docking platform 1600 can includea first stabilization device 1602 which can be in the form of a clamp1602. The first stabilization device 1602 can be configured to clamparound a tubular portion of catheter such as an introducer or accesssheath. In the illustrated embodiment, the clamp 1602 comprise pair ofclamp plates, 1604, 1606 that can be moved towards and away from eachother by a threaded post 1608 coupled to a handle 1610. Accordingly, inthe illustrated arrangement manipulation of a control such as rotationof the handle 1610 can bring the plates 1604, 1606 together to clamp theintroducer sheath (not shown) to the system 1500. In severalembodiments, other mechanisms can be used in the first stabilizationdevice 1600 to stabilize a catheter or introducer sheath such asfriction fit devices, collets, or devices that positively connect toengagement features on a handle of the introducer sheath.

As shown in FIGS. 34A, 34B and 35 , the clamp can be coupled to theupper plate 1504 base 1502 by an arm 1620. The arm 1620 can have an“L-shape” that positions the clamp 1602 above and forward along theaxial the axial direction of the upper plate 1504. The arm 1620 can becoupled to the upper plate such that movement of the upper plate 1504with respect to the lower plate 1506 causes axial movement of the clamp1602.

As best seen in FIG. 36 , distal docking platform 1600 can include asecond stabilization device 1650. In the illustrated embodiment, thesecond stabilization device 1650 can also be in the form of a clamp andcan be provided on the on the arm 1620. In the illustrated embodiment,the second stabilization device 1650 can be positioned on an elbow ofthe arm 1620. The second stabilization device 1650 can be used tostabilize another component of the mitral valve repair system descriedherein. For example, the second stabilization device 1650 can be used tostabilize the proximal end (or handle) of the suture lock deliverysubsystem (see e.g. FIG. 14 ).

The illustrated second stabilization device 1650 can include a clamp1652 for holding components. See FIG. 34A. In the illustratedembodiment, the clamp 1652 comprises pair of plates that can be movedtowards and away from each other by a control such as a screw similar tothe first stabilization device. Accordingly, in the illustratedarrangement rotation of the screw can bring the plates together to clampa portion of the suture lock delivery subsystem (not shown) to thesystem 1500. In several embodiments, other mechanisms can be used in theforward mount to stabilize the suture lock delivery subsystem such asfriction fit devices, or devices that positively connect to engagementfeatures on the suture lock delivery subsystem. As shown in FIG. 36 ,the arm may include a platform 1660 that can used to support a portionof the handle or other portion of the suture lock delivery subsystem. Inone arrangement, the second stabilization device 1650 can be used tosecure the front portion of the suture lock delivery subsystem while therear or back portion of a handle suture lock delivery subsystem rests onthe platform 1660.

With continued reference to FIGS. 35 and 36 , the system 1500 caninclude a second docking platform 1700, which in the illustratedembodiment can be positioned proximal to the first docking platform 1600and can also be referred to herein as the proximal docking platform1700. The proximal or second docking platform 1700 can be supportedabove the base 1502 by an arm 1702 that extends from the top plate 1504.The proximal docking platform 1700 can be generally at the sameelevation as the stabilization devices described above. The proximaldocking platform 1700 can include components of a suture managementsystem, which will be described in more detail below. The proximaldocking platform 1700 can include a third stabilization device 1710. Thedevice 1710 can include an elongate concave support surface such as aU-shaped channel extending in the axial direction that can be used tosupport components such as a handle of the ventricular anchor deliverysubsystem according to embodiments described herein. The second dockingplatform 1700 can be coupled to the top plate 1504 through the arm 1702such that movement of the top plate 1504 causes the platform 1700 tomove. Accordingly, in the illustrated arrangement, proximal dockingplatform 1700 and the distal platform 1600 can both carried by the upperplate and in several embodiments can be fixedly carried by the upperplate.

With continued reference to FIGS. 35 and 36 , the system 1500 caninclude a third docking platform 1800. The third docking platform 1800can be positioned between, in an axially direction of instruments beingmounted thereto, the first and second docking platforms 1600, 1700 whichas described above can be positioned in distally and proximally withrespect to each other. The third docking platform 1800 can also bereferred to herein as the intermediate docking platform 1800. Theintermediate docking platform 1800 can include a fourth stabilizationdevice 1802, which can be in the form of a vice or clamp. Theintermediate docking platform 1800 can be positioned can be positionedbetween the first and second docking platforms 1600, 1700. Theintermediate docking platform 1800 can include an adjustment mechanism1810, which in the illustrated embodiment can comprise a threadedengagement between the stabilization device 1802 and a lower rail 1812.The lower rail 1812 can be fixed with respect to the upper plate 1505. Ascrew 1816 can be rotated to move the stabilization device 1802 withrespect to the rail 1812 and upper plate 1504. In this manner, theadjustment mechanism 1810 can re-position in the fourth stabilizationdevice (and components coupled thereto) to the lower plate 1506, whichcan be attached to the stand or table, as needed. The adjustmentmechanism 1810 can include a lock to prevent movement. The intermediatedocking platform can be carried by the upper plate 1504. The adjustmentmechanism 1810 can also re-position in the fourth stabilization device(and components coupled thereto) to the upper plate 1504 and componentsthat are carried by or fixedly carried by the upper plate such as thedistal and proximal docking platforms (and components coupled thereto).

In one embodiment of use, the fourth stabilization device can be used tostabilize the delivery catheter such as according to the deliverycatheter 100 described above. In certain embodiments, the firststabilization device 1650 can be used to stabilize an introducercatheter while the fourth stabilization 1802 device can used tostabilize the delivery catheter 100 which is inserted through theintroducer catheter. In this manner, rotation of the screw 1816 canallow fine movement of the delivery catheter with respect the introducercatheter. That is movement of the intermediate docking platform can movethe delivery catheter with respect to the distal docking platform andthe introducer catheter mounted thereto.

With reference to FIGS. 37 and 38 , a suture management system 1700 caninclude at least one, two, three or more tensioning components that canbe used to hold each suture and assist to keep the sutures under tensionat all times, thus avoiding slack which could result in the pledgetsbeing pulled into the left atrium or the left ventricle from the forcecreated with each heartbeat, or additionally to avoid slack suturesbinding up in the left atrium or left ventricle, or even slack suturesbinding up with other chordae in the left ventricle.

For example, in one embodiment, the anchor suture may be attached to ananchor tension component 1720. The anchor tension component 1720 cancomprise a rotatable spool 1712 equipped with a torque limiting fixturesuch as a clutch to limit the amount of tension that can be applied to asuture (for example a suture coupled to the ventricular anchor) wrappedaround the spool. The anchor tension component 1720 can advantageouslyavoid or reduce the risk of the anchor being pulled out of the heartwall if too much tension is applied to the anchor suture. In anotherembodiment, the anchor tension component 1720 may comprise aspring-loaded post configuration to impart tension to the sutures. Inone embodiment, a proximal end of a suture coupled to the ventricleanchor 302 of the ventricular anchor delivery subsystem 300 can bewrapped around the anchor tension component 1720 after the ventricleanchor is deployed. In this manner, a constant tension can be applied tothe suture and the torque clutch limiting fixture can prevent or limitexcessive tension from being applied to the ventricle anchor. In oneembodiment, the torque limit of the clutch is between about 2 N to about5 N. In certain example embodiments, the torque limit of the clutch isbetween 2 N to 5 N.

With continued reference to FIGS. 37 and 38 , at least one, two, threeor more suture adjustment fingers 1770 can be provided allow adjustmentof the pledget suture tension on the leaflet. In use, a suture that iscoupled to a pledget can be attached to a tensioning force, such as aweight 1750 to provide the desired tension. In certain embodiments, theweight can be within the range from about 2 to about 8 grams. In certainexample embodiments, the weight can be within the range from 2 to 8grams. In the illustrated embodiment, the weights 1750 can be stored onthe proximal platform 1700 by providing weight mounts such as aplurality of holes, recesses or sockets that can receive the weights1750. The suture (e.g., a leaflet suture) can be placed in a sutureguide 1760 which can be notch or groove formed on the platform 1700. Theguide 1760 can be configured to allow the suture to axially slide whileproviding some constraint in lateral movement. The proximal dockingplatform 1700 can include at least one, two, three, or more sutureguides 1760. By hanging the end of the suture (for example a leafletsuture) attached to a weight 1750 over the edge of a platform 1700 aconstant tension can be applied to the pledget sutures which can beuseful in limiting or preventing suture tangling. As noted above, theplatform 1700 can be provided with more than one guide 1760 so that morethan one suture can be hung over the edge of the platform 1700.

As shown in FIGS. 37 and 38 , the platform 1700 can also include thesuture adjustment features or fingers 1770 that can be positioned nearor adjacent the notches or grooves 1760. The suture adjustment features1770 can comprise rotatable spools. Each spool can include a slot 1774through which a suture can extend. The rotatable spools 1770 can then berotated to adjust the tension on the suture.

The suture management system can provide a dynamic leaflet managementsystem. An advantage of using such a system is that the leaflet can beallowed to continue moving during the repair procedure in its “natural”state in response to the beating of the heart, but each pledget can bemaintained substantially in contact with the leaflet through applicationof substantially constant tension on the sutures. Additionally, suturetangling can be prevented or minimized through use of the system. Afurther advantage can include providing the physician with the abilityto individually adjust each suture for decreasing or increasing tensionto tailor the final movement of the leaflet, as appropriate. Forexample, in an embodiment of use, after the advancing the suture lock(embodiments described above), into the patient and before locking andcutting the sutures, the tensions on the sutures can be adjusted towhile viewing valve competency. This can be done by rotating the spoolsto increase or decrease the slack in the wire and the correspondingtension. Once the desired tension is achieved, the suture lock can beactivated as described above.

A plurality of sutures can be fixed to the suture management apparatus,including for example up to 4, and multiple suture managementapparatuses may be used, as needed. The apparatus components maycomprise any suitable sterilizable materials which meet the apparatusperformance requirements, including non-limiting examples such asstainless steel, acetal resin such as polyoxymethylene, PTFE, aluminum,3D printed resin materials, and the like.

Leaflet Tissue Anchor Deployment System

In accordance with a further aspect of the present disclosure, there isprovided an alternative leaflet tissue anchor deployment system.Referring to FIG. 39 , a needle deployment catheter 332 axiallyreciprocally carries a needle 336. A radio opaque marker band 1900 isprovided at the distal end of the needle deployment catheter 332, sothat positioning of the marker band 1900 can be visualized inrelationship to the mitral valve leaflet while the needle 336 isproximal retracted within the catheter 332.

In FIG. 39 , the needle 336 is illustrated in the distally advancedconfiguration. Needle 336 comprises a tubular body 1902 having asidewall 1904 and at least one flexibility enhancing feature such as aslot pattern. In the illustrated embodiment at least one serpentine slot1906 extends through the side wall. The serpentine slot 1906 may beformed in any variety of ways known in the art, such as by laser etchinga hypo tube. The serpentine slot 1906 enhances the lateral flexibilityof the needle 336 along a deflection zone, to facilitate aiming at theappropriate location on the mitral valve leaflet. The deflection zone istypically less than about 4 cm or less than about 2 cm in length, butlong enough to contain the entire length of the pledget. In certainexample embodiments, the deflection zone is typically less than 4 cm orless than 2 cm in length, but long enough to contain the entire lengthof the pledget.

The needle 336 terminates distally in a sharpened tip 1908 separatedfrom the tubular side wall 1904 by an inclined face 1910. Theinclination angle of the face 1910 will generally be within a range offrom about 30 degrees and 85 degrees, alternatively within a range offrom about 70 degrees and 80 degrees, and in one implementation is about75 degrees. In certain example embodiments, the inclination angle of theface 1910 will generally be within a range of from 30 degrees and 85degrees, alternatively within a range of from 70 degrees and 80 degrees,and in one implementation is 75 degrees.

At least one tissue retention element 1912 is provided operable topermit rapid, forcible powered advancement of the needle 336 distallythrough tissue, while being resistant to proximal retraction of theneedle 336 from the target tissue. The retention element 1912 maycomprise any of a variety of structures which extend radially outwardlyfrom the tubular sidewall 1904, such as at least one or two or five or10 or more barbs, annular rings or tabs. In the illustrated embodiment,the retention element 1912 comprises annular rings in the form of acontinuous helix 1914 which may be formed from a polymeric strand ormetal wire wrapped into a helix around the tubular body 1902. In oneimplementation, a helical wire such as a 0.008 inch wire is welded orotherwise secured to the tubular body 1902.

Distal advance of the needle 336 from the diploma catheter 332 at asufficient velocity enables the needle 336 to penetrate the leaflet,without the need for the leaflet stabilization anchor such as 406disclosed in FIG. 3 . Retention elements 1912 provide sufficientretention to retain the leaflet on the needle, until followingdeployment of the pledget. Thereafter, the needle may be proximallyretracted without rotation, or may be rotated, to unscrew and remove theneedle from the leaflet.

If additional leaflet stabilization is desired, stabilization may beachieved by the temporary leaflet anchor disclosed previously herein, orby alternative mechanical techniques of grasping or pinching the leafletor by suction or freeze-grabbing with a cryo-catheter. These techniqueswould include a cryo-catheter of the type used in ablation procedures tofreeze a target tissue. These cryoablation-catheters used for atrialfibrillation often attach themselves to the mitral leaflets accidentallyand need to be deactivated to release the attached leaflets. This samecryo attachment can be used to locate and isolate the leaflet inquestion for stabilization during deployment of the leaflet anchordeployment needle. The cryo catheter uses a gaseous exchange (NO orArgon) to drop the temperature of the tip of the catheter, and can reachtemperatures as low as minus 75 degrees Celsius.

Actuator Control System

Deployment of the mitral leaflet anchor described herein is accomplishedby piercing the leaflet from the atrial side of the valve. In order toavoid the need for a grasping structure to capture and support theleaflet during leaflet puncture, and use a needle such as that shown inFIG. 39 , the distal ejection of the leaflet anchor deployment needlecan be timed to correspond with peak (systolic) pressure in theventricle which occurs at about or around the QRS wave. Thissynchronizes piercing of the leaflet with mitral valve closure so thatsystolic pressure within the ventricle provides the necessary back upsupport during penetration of the leaflet from the atrium.

Timing of leaflet needle launch with the cardiac cycle can beaccomplished manually by the clinician, or can be partially or fullyautomated depending upon the desired implementation. For example, avisual or audio signal or fluoro image may alert the clinician to thetiming of the QRS complex, allowing the clinician to press the launchtrigger or other control to deploy the needle. Since clinician reactiontimes can vary, it may be desirable to partially or fully automate theneedle launch procedure.

For example, a needle 338 may be provided with an automated needledriver, such as a solenoid carried by the proximal end of the catheter.The solenoid is activated to distally project the needle in response toan activation signal that corresponds in time to a target time in thecardiac cycle, such as during closure of the mitral valve.

Alternatively, the activation signal may be in the form of a visual,tactile or auditory signal to the clinician, in response to which theclinician pushes a control such as a button or slider to manuallyadvance the needle, or pushes a control that activates anelectromechanical or mechanical needle driver.

In another implementation of the disclosure, needle deployment can beaccomplished manually by the clinician, but only after disengagement ofa lock out. In this implementation, a removable mechanical interferencemay be created at or linked to a proximal portion of the needle shaft. Adistally facing interference surface may be carried by a radiallyoutwardly extending tab or annular flange coupled to the needle, or adistal surface of an aperture extending through the needle. For thepresent purpose, ‘needle’ refers to the needle itself, as well as anyproximally extending structure (e.g., extension tube or rod) that ismechanically linked to and moves with the needle as will be understoodby those of skill in the art.

A proximally facing interference surface is configured to be movablebetween an engaged configuration in which it engages in an interferencefit with the distally facing interference surface on the needle, and adisengaged configuration in which the distally facing interferencesurface and associated structure is free to advance distally to ejectthe needle. The proximally facing interference surface may be carried ona stop such as an axially movable pin or a pivotable or sliding leverwhich is movably carried by the proximal handpiece. A stop driver suchas a solenoid is configured to move the stop between the engaged anddisengaged configurations.

The stop may be initially engaged, to prevent deployment of the needle.In response to an activation signal indicating the target time (e.g.,during or about or around at the QRS complex), the stop is retractedinto the disengaged configuration. This prevents the clinician fromprematurely deploying the needle, but allows manual deployment of theneedle at the desired target time. The stop may be automaticallyreturned to the engaged configuration following a preset time windowfollowing the activation signal, to prevent late deployment of theneedle and create a narrow window in which the clinician is allowed tolaunch the needle. If the clinician failed to timely deploy the needlewithin the window, the opportunity to launch the needle will reappearwith subsequent QRS complex occurrences.

A variety of techniques have been developed to detect the QRS complexdirectly, or a proxy for that point in the cardiac cycle. Directdetection techniques include power spectrum analysis, bandpassfiltering, differentiation, template matching, and waveformfeature-dependent real-time techniques. Proxies include blood pressuresuch as measured intravascularly in the arterial or venous side orwithin an atrium or ventricle of the heart, or measured noninvasivelysuch as peripheral blood pressure. Venous side measurements can serve asa proxy for the timing of the QRS complex since the aortic valve is openwhen the mitral valve is closed, leaving a fingerprint on the cyclicvenous pressure curve. The data from any of the foregoing sources maydesirably be adjusted to take into account any time delay from the trueQRS complex, depending upon the desired time sensitivity. The ECG signalmay be obtained from a conventional ECG monitor which will normallyalready be present and in operation in the surgical suite.

A typical ECG waveform consists of a P wave indicating atrialdepolarization, a QRS complex indicating ventricular depolarization, a Twave indicating ventricular repolarization, and a possible U wave insome cases indicating the extension of the repolarization. The dominantactivity of an ECG usually relates to identification of the QRS complexin real time, for various monitoring and diagnostic purposes. The QRScomplex or wave normally lasts about 80 to 120 ms in duration andcorresponds to the commencement of ventricular contraction and ejectionof blood via the aortic valve. In certain example embodiments, the QRScomplex or wave normally lasts 80 to 120 ms in duration and correspondsto the commencement of ventricular contraction and ejection of blood viathe aortic valve. This also corresponds to pressure responsive closureof the mitral valve, which is significant for the purpose of the presentdisclosure.

FIGS. 40-45 depict a system which provides control of an actuator insynchrony with heart 10. As used herein, actuator refers to anythingthat is activated in response to a control signal triggered by an eventin the cardiac cycle, such as a visual, audio or tactile feedback to theclinician, an automated needle firing mechanism, or a lockout mechanismin a manually operated needle deployment embodiment, that prevents theclinician from deploying the needle until the actuator unlocks thefiring mechanism.

An overview of such a system is shown in FIG. 40 and is seen to comprisea component to sense the cardiac cycle 212, a component to generate atrigger pulse for the actuator in response to the sensed cardiac cycle218, a component to position the leading edge of the trigger pulse at aspecified time within the cardiac cycle 232, a component to define thewidth of the trigger pulse to occur during the cardiac cycle 234, and acomponent to control the firing of the actuator in response to thetrigger pulse and for a period in response to the defined width 222.

In particular, electrocardiogram (ECG) unit 212 electrically connects toheart 10 of a patient so as to sense the cardiac cycle and provide ECGsignal 216. ECG unit 212 may be connected to the heart in any knownmanner for sensing cardiac signals including surface mounted electrodestypically adhesively mounted to the patient's chest, as well as internalor intracavitary electrodes. As an alternative, the sensing connectionmay further be incorporated integrally with the catheter 332, such asthrough the provision of one or more electrical leads extending throughthe catheter 332 to conduct electrical signals or operate a sensor(e.g., pressure sensor) or electrode at the distal end of the catheter332. Electrodes may be either of unipolar design, in which case asurface contact may be used or bipolar design. The electrical lead mayextend proximally through catheter 332 and end in a standard electricalconnector which may then be removably connected to the ECG unit 212 andcommunicate sensed signals 216 thereto.

Signal 216 is delivered to trigger generator 218. Trigger generator 218provides a trigger pulse 220 to actuator firing circuit 222. Actuatorfiring circuit 222 energizes actuator 224 such as to fire the needle orremove a barrier that inhibited the clinician from prematurely firingthe needle as has been discussed.

The position of trigger pulse 220 in the heartbeat cycle of ECG signal216 is determined by pulse positioning circuit 232. The width of thepulse 220 and its duration during the heartbeat cycle is determined bypulse width circuit 234. Trigger generator 218, as well as pulsepositioning circuit 232 and pulse width circuit 234, may be included asan additional board in a PC or a microprocessor 236, in which case thesystem can be controlled through a computer keyboard and suitablesoftware. PC 236 and ECG 212 may have separate monitors, or they mayhave a single monitor 238 which displays both the ECG and informationabout or around the trigger pulse 220.

Trigger generator 218 may include a marker pulse circuit 250 whichprovides marker pulse 252 and trigger pulse circuit 254 which respondsto marker pulse 252 to create trigger pulse 220. Alternatively, markerpulse circuit 250 is included in the ECG itself in some cases.

This can be better understood with reference to FIG. 44 , where ECGsignal 216 may be seen as consisting of a series of heartbeat cycles 256a, 256 b, 256 c each of which contains the waveforms Q, R, S and T.Where waveform R crosses preselected threshold 258, marker pulses 252 a,252 b, 252 c are created. Trigger pulses 220 a, 220 b, 220 c are thencreated by trigger pulse circuit 254. The position of the leading edge260 and the overall width 262 of each trigger pulse 220 is determinedrespectively by pulse positioning circuit 232 and pulse width circuit234. In response to trigger pulse 220, a firing pulse 264 indicated as264 a, 264 b and 264 c, FIG. 24 , is created to energize actuator 224.

In FIG. 42 , actuator firing circuit 222 is shown to include gate 270which generally inhibits the delivery of trigger circuit 220 to actuatorlaser power supply 272 (when relevant) in actuator unit 224. Theinhibiting effect of gate 270 can be overcome when the operatoractivates a switch 274. Trigger pulse 220 is still inhibited, however,by arming circuit 276 which in turn can have its inhibiting effectovercome by the operation of arming switch 278. This double lock on thedelivery of trigger pulse 220 to actuator power supply 272 ensures thatthe firing of the actuator is truly desired and not accidental. Thus theoperator must first arm the system by operating arming switch 278 toenable arming circuit 276. Then and only then is he able to pass thenext occurring trigger pulse 220 through gate 270 to the actuator powersupply 272 by actuating switch 274. Further details of a suitable designfor synchronizing a trigger signal with the QRS wave can be found inU.S. Pat. No. 5,674,217 to Wahlstrom, et al, filed Nov. 16, 1993, thedisclosure of which is hereby incorporated in its entirety by referenceherein.

Meltable Suture

The disclosed system can, in certain embodiments, utilizepolytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene(ePTFE) sutures due to their desirable tensile strength and relativelylow creep. However, PTFE and ePTFE sutures are not easily severable bycutting or by melting.

In order to overcome this challenge, some embodiments of the presentdisclosure relate to sutures wherein at least a portion of the suture ismeltable. In some embodiments, the suture can be a bi-component suture,wherein a distal end of the suture comprises a meltable suture materialand the proximal end of the suture is a non-meltable suture material. Insome embodiments, the distal portion of the suture comprises less than50% of the total length of the suture. In other embodiments, theproximal end of the suture comprises greater than or equal to the totallength of the suture. In another embodiment, the bi-component suture maycomprise one portion of a meltable suture, wherein the meltable portionis a relatively small meltable zone with non-meltable suture material oneither side of the meltable zone. The meltable zone should be located ata position on the suture so that it does not impact the tensile strengthor creep resistance of the implanted prosthetic chordae. When abi-component suture is used, the junction between the meltable portionand the non-meltable portion should be placed proximate to the locationof the suture lock or the point at which the suture will be tied orknotted so as not to affect the strength of the suture. None or arelatively small portion of the meltable suture should be under tensionduring the normal functioning of the heart after implantation of theprosthetic chordae. The bi-component suture should have enough tensilestrength over the entire length of the suture, and especially at anyinterface of a meltable portion with a non-meltable portion, so that thephysician can provide enough tension on the suture during the tensioningstep so that the suture does not break when tension is applied tocorrect the mitral valve regurgitation.

FIG. 46 illustrates one embodiment of a schematic side view of a heart,wherein the left atrium 3301 and the left ventricle 3302 are shownseparated by the posterior and anterior mitral valves (not labeled). Inthis embodiment, a pledget 3303 is secured to the ventricular side ofthe leaflet with one portion of non-meltable suture 3304 extending fromthe pledget into the left atrium 3301 passing to the left ventricle 3302between the two leaflets. In the left ventricle 3302, a tissue anchor3305 is secured to the heart tissue using a helical anchor 3306.Non-meltable suture 3308 is joined to non-meltable suture 3304 with knot3307. Meltable suture 3309 shows only a portion of the suture afterhaving been cut with the remaining distal end of the meltable suturehaving been retracted through the catheter (not shown). In thisembodiment, all of the tension of the beating heart is on sutures 3304and 3308 with substantially no tension on meltable suture 3309. Thelength of the distal ends of the sutures should be as small as possible.Note that only one distal end of sutures 3304 and 3308 are shown.

The system can further comprises a suture cutter. Once the tension isset in the one or more sutures and the mitral valve regurgitation iscorrected or minimized, the suture cutter can be advanced through thecatheter placed over the distal ends of one or more of the sutures inorder to melt the meltable suture, thereby severing the suture. Thedistal end of the meltable suture can be retracted through the catheterto be removed from the patient. Each of the one or more sutures can becut one at a time or two or more sutures can be melted at one time. Thesuture cutter comprises a heat source, for example, a coil that can beenergized in order to heat the coil so that the temperature proximate tothe coil rises above the melting temperature of the meltable suture.

FIG. 47 illustrates an embodiment wherein a suture cutter 3310 isadvanced through the catheter (not shown) over the distal ends 3311 ofthe sutures and to the suture lock 3312. The suture connected to theleaflet pledget 3303 and the suture connected to the anchor 3306 havingbeen tensioned to minimize or correct mitral valve regurgitation areclamped in the suture lock 3312 so that sutures are not able to movethrough the suture lock 3312 as tension is applied to the sutures duringthe normal functioning of the heart. The suture cutter 3310 can comprisea heating source, for example, a heater coil 3315, a short tubecomprising a heater housing 3316 that is coaxial to the heater coil3315, which may serve to insulate the heart structure from the heat, andhas a larger inside diameter than the outside diameter of the heatercoil, a hypotube 3317, which may serve to prevent blood from enteringthe catheter, and an insulated conductor 3318 which provides electricalenergy to the heater coils to provide a temperature above the meltingpoint of the meltable suture. The transmission of the electrical energyto the heater coil is actuated by the physician when the suture cutterhas been moved into position and can be deactivated by the physicianfollowing the cutting of the sutures. In FIG. 47 , the non-meltablesuture (not labeled) extends just past the suture lock (toward thedirection of the suture cutter) and the meltable portion of the sutureis located coaxial with and inside the inner diameter of the coils ofthe suture cutter. In this way, once the distal portion of the suture orsutures has been removed, only a relatively short portion of sutureends, or tails, extend beyond the suture lock, and the remaining sutureportions that extend to the leaflet and to the ventricular anchor arenon-meltable sutures and remain securely clamped in the suture lock.

The meltable suture component(s) can include, but are not limited to,suitable melting compositions including polyolefin, polyethylene,ultrahigh molecular weight polyethylene, polypropylene, polyester,polyamide, polyglycolide/L-lactide, polyethylene terephthalate,silicone, collagen or other amino acid protein and a combinationthereof. In some embodiments, a portion of the suture is meltable usingany one of the previously described polymers as the meltable portion ofthe suture or meltable zone. The non-meltable portion of the suture canbe PTFE or ePTFE.

Suture Lock Guide

The embodiments discussed above can provide effective mechanisms fortranscatheter mitral chordal repair, e.g., implanting and effectingprosthetic chords. Embodiments discussed below build on many of theseconcepts to provide additional advantages. For example, the normalcardiac functions of the heart can cause mitral chordal repair systemsto undergo cyclic motion and loading. In particular, a suture lock orother components (e.g., the suture) can oscillate or otherwise movewithin the ventricle as a result of the heart's normal compressioncycles. This motion is generally shown in FIG. 48 , where the arrows4180, 4182 generally indicate motion of a suture and motion of a suturelock, respectively.

The oscillatory motion of the sutures and the suture lock can contributeto excessive wear on the suture, particularly at their junctures withthe suture lock. The resulting wear could eventually result in thepremature deterioration and failure of the prosthetic chord. Inparticular, in some systems the sutures pass through the suture lock,e.g., along its longitudinal direction. The sutures connecting themitral leaflet and the anchor extend from the one end of the suture. Theweight of the suture lock will pull the other end of the suture lockdown slightly relative to the true orthogonal, and this angular movementcan force the sutures against the suture lock. If the suture lockincludes relatively sharp angles, those angles can introduce shearingforces that can cause the sutures to prematurely break. For example,FIG. 49 illustrates a suture lock 4206 whose orientation results in thesuture 4211 located against a sharp angle on the suture lock 4206.During movement of the suture 4211 and suture lock 4206, the sharp angleintroduces shearing forces on the suture 4211. Suture 4244 can besubjected to similar shearing forces. These shearing forces can beamplified by rotational movement of the suture lock 4206, as representedby arrow 4207.

Furthermore, increasing tension on the sutures tends to rotate thesuture lock into an orientation that is somewhat orthogonal to thesutures, as shown in, e.g., FIG. 50 . This movement, in addition to themass and resulting inertia of the suture lock during other movements,can add a high-impulse force to the sutures, e.g., as part of a“whipping” motion. In some situations, this could cause suture materialsto shatter due to their visco-elastic characteristics. Accordingly,movement of the suture lock (e.g., relative to the anchor) can be anadditional source of potential failure for mitral chordal repairsystems.

Furthermore, the changing tension on the sutures can alter the length ofthe prosthetic chord, which can negatively impact the effectiveness ofthe prosthetic chord, e.g., at resolving MR. For example, and as shownin FIGS. 49 and 50 the suture lock 4206 assumes a particular orientationrelative to the sutures 4211, 4244 when tension on the sutures islowered or removed. In this situation, the prosthetic chord has aparticular length, e.g., as measured between the leaflet (where thesuture 4244 is coupled to the leaflet) and the ventricular tissue (wherethe suture 4211 is secured to the anchor 4202). In effect, part of thesuture (e.g., suture 4211) is wound around the suture lock 4206 and doesnot contribute to the overall length of the prosthetic chord. However,when tension is applied to the sutures, that tension will rotate thesuture lock 4206, as shown in FIG. 50 . As a result, the portion of thesuture 4211 previously wound around the suture lock 4206 is pulled awayfrom the suture lock 4206, resulting in a corresponding increase in thelength of the prosthetic chord. In some situations, this increase isaround 0.10 mm to 0.30 mm, though in some cases it can be as much as0.50 mm. In some embodiments, the amount of change will depend on thewidth of the suture lock 4206 and the angle of rotation of the suturelock 4206. In some situations, these changes in length with reduce theefficacy of the prosthetic chord, causing the physician to readjust theprosthetic chord or necessitating reinstallation of the prostheticchord.

Embodiments of the present disclosure are designed to mitigate theeffects of some or all of these issues, as well as providing additionaladvantages that improve the efficacy of the prosthetic chord and/orincrease ease of implementation. For example, some embodiments include atranscatheter mitral chordal repair system designed to reduce oreliminate suture movement relative to the suture lock and other systemcomponents. Certain embodiments further serve to decrease the amount ofunrestrained suture within the ventricle. Some embodiments provide for aprosthetic chord that incorporates a prosthetic papillary muscle, whichcan reduce the whipping effect.

Certain embodiments are designed to limit or eliminate movement of thesuture lock relative to the anchor. These embodiments can also limit oreliminate movement of the sutures relative to the anchor, at least at alocation near the anchor. As a result, these embodiments reduce wear onthe sutures and promote longer lifetime for the mitral chordal repairsystem.

In some embodiments, the transcatheter mitral chordal repair systemcreates a prosthetic papillary construct using a retaining member alsoreferred to herein as a suture lock guide (e.g., a socket or sleeve)that constrains motion of the suture lock. An example of such a suturelock guide was described above with reference to FIGS. 2A and 2B and wasin the form of a tubular sleeve 78. Motion of the sutures relative tothe suture lock can also constrained near the suture lock, which reducesthe wear on the sutures. In some embodiments, the transcatheter mitralchordal repair system includes an suture lock guide also referred toherein as an anchor socket that restricts motion of the suture lock,relative to the anchor, as well as motion of the sutures relative to thesuture lock.

Embodiments discussed herein can provide prosthetic systems designed tomaintain integrity through about 800 million cycles, or about 20 years.In certain example embodiments, embodiments discussed herein can provideprosthetic systems designed to maintain integrity through 800 millioncycles, or 20 years. Disclosed are arrangements prosthetic chords thatcan remain for a minimum of 400 million cycles, or about 10 years. Incertain example embodiments, disclosed are arrangements prostheticchords that can remain for a minimum of 400 million cycles, or 10 years.These prosthetic chords will perform under the range of typicalsituations and environments without excessive structural damage and/orfunctional impairment after 400 million cycles, i.e., without exhibitingholes, tears, gross delamination, severing, fraying, incomplete leafletcoaptation, excessive regurgitation, and the like.

FIGS. 51 and 52 illustrate components of a transcatheter mitral chordalrepair system 4300, according to some embodiments of the presentdisclosure. That system 300 provides one or more prosthetic chords usingone or more sutures or tethers deployed into a beating heart withoutextracorporeal circulation using a transcatheter delivery system. Theseembodiments can reduce wear on anchoring sutures or tethers over time byusing a retaining member or restraining member, which in someembodiments includes a stent-like or stent graft-like socket anchored toa securing device or anchor located on the epicardium. The deliverysystems and techniques discussed above and/or in PCT/US2017/069046 andPCT/US2019/021480, which are incorporated by reference herein, may beemployed to deliver the components of system 4300.

FIGS. 51 and 52 illustrate an anchor 4302, a retaining member 4304, anda suture lock 3406. In several of the embodiments illustrated herein,the retaining member 4304 is a socket or sleeve which can be, in certainaspects of the disclosure, similar to the sleeve or socket 78 descriedabove with respect to FIGS. 2A and 2B. In other embodiments, theretaining member may be a pin, a hook, a clasp, a claw, a catch, abuckle, a suture, or the like. The anchor 4302 may be—in part or infull—any of the anchors disclosed above and/or in PCT/US2017/069046 orPCT/US2019/021480. Also shown in FIGS. 51 and 52 are sutures 4308 and ananchor suture 4310. While two sutures 4308 are shown in FIGS. 51 and 52, only one suture or more than two sutures may be used. The sutures 4308can be coupled to one or more leaflets of the mitral valve, e.g., usingpledgets for example using the systems or techniques described aboveand/or in PCT/US2017/069046 or PCT/US2019/021480. Accordingly, thesutures 4308 may be referred to as pledget sutures. The anchor 4302 canengage the ventricular tissue, and the retaining member 4304 can receiveand secure the suture lock 4306 and the sutures 4308, 4310.

The suture lock guide or retaining member 4304, in some embodiments,restricts motion of the sutures 4308 and/or the suture lock 4306 whilefacilitating installation, adjustment, and eventually operation of thesutures 4308 as part of a prosthetic chord. For example, in someembodiments, the retaining member (also referred to herein as suturelock guide) 4304 is configured to selectively couple and decouple withthe suture lock 4306. When coupled to the suture lock 4306, theretaining member 4304 may provide securing forces strong enough toprevent slippage during cardiac cycles (e.g., with non-limiting forcesranging up to approximately 1 N, 1.5 N, 2.0 N, 2.5 N, or 3 N) yet stillenable a physician to pull on the sutures 4308 to tighten or loosen thesutures 4308 without displacing the suture lock 4306. In otherembodiments, the retaining member 4304 is designed to secure the sutures4308 and the suture lock 4306, such that any adjustment to the sutureswill require the physician to remove the suture lock 4306 from theretaining member 4304, adjust the sutures 4308, and then re-insert thesuture lock 4306 back into the retaining member 4304. Removing thesuture lock from the retaining member 4304 may in certain instancesrequires larger forces, e.g., forces above approximately 6 N toapproximately 9 N, or even in excess of 10 N in some embodiments. Inother words, in some non-limiting embodiments the retaining member 4304is configured to exert retaining forces on the suture lock that resistforces between approximately 4 N to at least 10 N, including forces ofapproximately 4.5 N, 5 N. 5.5 N, 6 N, 6.5 N, 7 N, 7.5 N, 8 N, 8.5 N, 9N, 9.5 N, 10 N, 10.5 N, or 11 N.

As a result of the retaining member 4304, the suture lock 4306 canmaintain a positional relationship with the anchor 4302. For example, asthe heart tissue moves during cardiac cycles, the retaining member 4304will resist displacing forces exerted on the suture lock 4306 (e.g., viathe sutures 4308). In some embodiments, the retaining member 4304transfers forces exerted on the suture lock 4306 to the anchor 4302. Thedisplacing forces may range up to approximately 1 N, though in somesituations those forces may be around 1.5 N or up to approximately 3 N.

In some embodiments, a retaining member 4304 is a socket formed byinverting a vascular graft tube. The retaining member 4304 is designedto be radially compliable to permit the suture lock 4306 to enter theretaining member 4304 while providing constraining forces. The retainingmember 4304 can also be also axially stiff and wear resistant. Axialstiffness enables the suture lock 4306 to enter the retaining member4304 without buckling. Wear resistance can be minimized with a PTFE-PTFEinteraction.

For example, in the embodiments shown in FIGS. 51 and 52 , the retainingmember 4304 includes an interior surface 4330 defining a chamber thatreceives and secures the suture lock 4306 and/or the sutures 4308. Insome embodiments, the retaining member 4304 is made of a material thatis flexible enough to accommodate the suture lock 4306 and even permitadjustment of the sutures 4308 relative to suture lock 4306 after thesuture lock 4306 is inserted into the retaining member 4304. In someembodiments, the retaining member 4304 is radially compliable to permitthe suture lock 4306 to enter and couple with the retaining member 4304.The retaining member 4304 may couple with the suture lock 4306 using aninterference fit or the like.

In some embodiments, the retaining member 4304 couples with an exteriorsurface of the suture lock 4306, e.g., a portion of the exterior surfacelocated between a proximal end and a distal end of the suture lock 4306.For example, the retaining member 4304 contacts opposite sides of thesuture lock 4306 to couple with the suture lock 4306. In otherembodiments, the retaining member 4304 contacts the suture lock 4306 atthree or more points to constrain movement of the suture lock 4306relative to the anchor 4302. In FIGS. 51 and 52 , the retaining member4304 and the suture lock 4306 are both cylindrically shaped, and theretaining member 4304 engages the suture lock 4306 about or around itscircumferential perimeter. In FIGS. 51 and 52 the engaging contactbetween the retaining member 4304 and the suture lock 4304 extendlongitudinally along the circumferential surface of the suture lock. Insome embodiments, the engaging contact can extend over half of thelongitudinal extent of the suture lock. In other embodiments, theengaging contact can extend over a percentage of the longitudinal extentof the suture lock ranging from approximately 20% to approximately 98%.In other embodiments, that range may be more limited, e.g.,approximately 40% to approximately 80%, approximately 50% toapproximately 70%, or combinations of the ranges discussed herein (aswell as any subranges with the ranges explicitly mentioned as examples).

FIGS. 51 and 52 also illustrate a support member 4354 or support coilthat can reinforce the material of the retaining member 4304 as theretaining member 4304 secures the suture lock 4306 and the sutures 4308.In some embodiments, the anchor 4302 and the support member 4354 are twoseparate structures that may be integrated, while in other embodimentsthe anchor 4302 and the support member 4354 are unitarily formed of asingle material. The support member 4354 may extend along a length ofthe retaining member 4304 so as to terminate at a location that issubstantially aligned with a distal surface of the suture lock 4306 whenfully inserted into the socket 4304. In other embodiments, the supportmember 4354 may extend along a length of the retaining member 4304 so asto terminate at a location that is substantially aligned with an upperportion of the suture lock 4306 but located below (or proximal of) thedistal surface of the suture lock 4306. The support member 4354 contactsan outer surface of the retaining member 4304. A bonding material 4362is placed along the support member 4354 and the exposed outer surface ofthe retaining member 4304. This bonding material 4362 may also contactthe exposed outer surface of an anchor hub 4338.

In some embodiments, the support member 4354 provides axial rigidity toprevent folding as the suture lock 4306 enters the retaining member4304. For example, in FIGS. 51 and 52 , the support member 4354 is asupport coil that resists longitudinal forces exerted on the retainingmember 4304, e.g., by the suture lock 4306 as it is pressed into theretaining member 4304. This additional rigidity holds the retainingmember 4304 steady, thereby increasing ease of installation. In otherembodiments, the retaining member 4304 may be formed of other materialsand may be formed in other configurations. For example, the supportmember 4304 may be formed of multiple metal strips longitudinallyextending along the outer surface of the retaining member 4304 or may beone or more cylindrical cuffs longitudinally spaced along the othersurface of the retaining member 4304. In some embodiments, the retainingmember 4354 is formed of nitinol tines or similar material.

The support member 4354, in some embodiments, provides additionalsecuring forces that maintain the suture lock 4306 and sutures 4308within the retaining member 4304. For example, in FIGS. 51 and 52 , thesupport member 4354 is a support coil. In some embodiments, as thesuture lock 4306 is pressed into the retaining member 4304, the supportcoil linearly compresses, and its inner diameter increases toaccommodate the suture lock 4306. The compressive forces of the supportcoil (e.g., as it recoils back towards its original configuration andsmaller inner diameter) increases the frictional forces between theretaining member 4304 and the suture lock 4306. Furthermore, in someembodiments, the support coil is configured to linearly extend inresponse to forces pulling the suture lock 4306 from the retainingmember 4304. This will further decrease the inner diameter of thesupport coil, augmenting the frictional forces between the retainingmember 4304 and the suture lock 4306.

In some embodiments, the support member 4354 terminates at anintermediate portion of the retaining member 4304 below a distal portionof the retaining member 4304. In this manner, the distal portion of theretaining member 304 above the support member 4354 exerts relativelysmaller forces on the suture lock 4306 and sutures 4308, compared to thecombination of the retaining member 4304 and support member 4354. Withthese relatively smaller forces, the physician can adjust the tension orlength of the sutures 4308 without displacing the suture lock 306 fromthe retaining member 4304.

Stated differently, in some embodiments the retaining member 4304 (aloneor in combination with the support member 4354) provide sufficientforces to retain the suture lock 4306 during cardiac cycles (e.g.,forces from approximately 0 N to approximately 4 N). Forces exerted onthe sutures 4308 by the physician (e.g., pulling the proximal ends ofthe sutures 4308) and/or leaflet (e.g., pulling the distal ends of thesutures 4308) allow the physician to adjust the sutures 4308 relative tothe suture lock 4306, while the suture lock 4306 remains secure withinthe retaining member 4304, in order to adjust the length of the sutures4308 between the suture lock 4306 and the leaflet. The magnitude of theforces required to move the sutures 4308 in some embodiments range from1 N to 2 N. Thus, the retaining member 4304 (alone or in combinationwith the support member 4354) secures the suture lock 4306 relative tothe anchor 4302 during adjustment of the sutures 4308. One the suturelock 4306 engages the sutures 4308 (as described below), the retainingmember 4304 secures the suture lock 4306, which secures the sutures 4308as part of the prosthetic mitral chord.

Still referring to the embodiments described with reference to FIGS. 51and 52 , the retaining member 4304 is a generally cylindrical structure.The retaining member 4304 may be a stent or stent-graft structure formed(in whole or in part) of ePTFE. The materials forming the retainingmember 4304 can promote tissue ingrowth to further secure the anchor4302 and/or the prosthetic chord. The materials forming the retainingmember 4304 can include a film microstructure in which the fibrillarorientation is in a direction substantially parallel the longitudinalaxis of the retaining member 4304. In this manner, any longitudinalmotion of sutures 4308, (e.g., ePTFE sutures) will be in line with thefibrillar orientation to further reduce friction and wear on thesutures.

Stated differently, in some embodiments, the retaining member 4304 ismade from an ePTFE graft, elastomer, other polymer, or combination ofthese materials. For example, in some embodiments the retaining member4304 is constructed from ePTFE stretch graft and may be densified toenhance column strength. The retaining member 4304 in some embodimentsis partially or fully bio-resorbable or bio-absorbable and providestemporary fixation until, e.g., biological fibrous adhesion between thetissues and other components. In some embodiments, the retaining member4304 includes a mesh designed to enhance biocompatibility and fibrosisfollowing implantation. All or part of the surface of the retainingmember 4304 may be configured to promote tissue growth onto and/orthrough its surface. In one example, this growth is achieved byproviding a relatively rough and/or porous surface. Another example isto have one or multiple holes drilled through the material of theretaining member 4304, allowing scar tissue fibrocytes to grow throughthese holes and thereby add strength to the fixation. Additionally,biological coatings of the types known in the art can be included on thesurface of the retaining member 4304 to promote healing and tissuegrowth.

The suture lock 4306 can be secured within the retaining member 4304,where it is aligned coaxially with the anchor 4302. This configurationcan minimize or eliminate the relative motion of the suture lock 4306with respect to the sutures 4308, at least within the retaining member4304. This configuration can also minimize or eliminate movement of thesutures 4308 within the retaining member 4304 relative to the suturelock 4306 and the anchor 4302.

In some embodiments, the length of the support member 4354 ranges fromapproximately 0.5 mm to 3.0 mm. In other embodiments. In someembodiments, the length of the support member 4354 varies from a quarterof the length of the retaining member 4304 up to the full length of theretaining member 4304.

Other embodiments (e.g., embodiments shown in FIGS. 2A, 2B, 55 ) do notinclude a support member 4354. Some of these embodiments provide varyingrestraining forces through other mechanisms, including by varying thematerials and/or surface treatments used to construct different portionsof the socket or by varying the size of the socket at differentlocations. Still other embodiments make use of external tools thatexpand an upper portion of the socket or otherwise reduce therestraining forces on the suture lock and sutures at that upper portion.

As can be seen in FIG. 52 , the sutures 4308 can be located between anouter surface of the suture lock 4306 and an inner surface of theretaining member 4304. In some embodiments, these surfaces (in whole orin part) are designed to facilitate securement of the sutures 4308, forexample, providing surfaces with higher coefficients of friction. Inother embodiments, these surfaces (in whole or in part) are designed tofacilitate easy adjustment of the sutures 4308, providing surfaces withlower coefficients of friction. One or both of these surfaces may beresilient to help secure the sutures 4308 while enabling adjustment.

Securing the sutures 4308 between the suture lock 4306 and the retainingmember 4304 can provide additional advantages. For example, the suturelock 4304 and the retaining member 4304 can maintain tension on distalportions of the sutures (e.g., portions extending from the suture lock4306 towards the leaflets) even when tension on proximal portions of thesutures (e.g., portions extending from the socket 4306 towards thephysician or proximal end of the catheter) changes or is eliminated. Asa result, once the suture lock 4306 is placed within the retainingmember 4304, thereby securing the sutures 4308, any tension change inthe proximal portions of the sutures (e.g., if the physicianaccidentally bumps the catheters) will not substantially affect tensionin the distal portions of the sutures 4308. Accordingly, physicians neednot maintain each suture 4308 in tension during the operation.Furthermore, in some embodiments, the suture lock 4306 and retainingmember 4304 can be used to maintain tension in a distal portion of onesuture during adjustment of another suture.

As shown in FIG. 52 , in some embodiments the retaining member 4304includes an upper enlarged portion 4376 and a lower enlarged portion4378. These enlarged portions 4376, 4378 can provide additional axialrigidity to prevent folding or buckling as the suture lock 4306 ispushed into the retaining member 4304. In addition, the enlarged upperportion 4376 could incorporate a band that increases rigidity andprovides a radiopaque marker. In some embodiments, the upper enlargedportion 4376 includes an outer surface located further out (e.g., alonga radial direction) than a lower portion of the socket. The upperenlarged portion 4376 can include an inner surface that is locatedfurther out (e.g., along a radial direction) than a lower portion of theretaining member 4304. For example, the upper enlarged portion 4376could form a tapered shape (e.g., a funnel) to assist in receiving thesuture lock 4306.

The sutures 4308, 4310 may be formed from surgical-grade materials suchas biocompatible polymer suture material. Examples of such materialinclude 2-0 ePTFE (polytetrafluoroethylene) or 2-0 polypropylene. Insome embodiments the sutures 4308, 4310 are inelastic. In otherembodiments, the sutures 4308, 4310 can be partially or fully elastic.The sutures 4308, 4310 in some embodiments are be partially or fullybio-resorbable or bio-absorbable and provide temporary fixation until,e.g., biological fibrous adhesion between the tissues and othercomponents. Thus, the sutures 4308, 4310 may be formed from abiocompatible material (e.g., nitinol, ePTFE, PTFE, PET, or polyester,nylon, Silicone, collagen or other amino acid protein, stainless steel,cobalt chrome, combinations of these, or the like).

FIGS. 51 and 52 illustrate an anchor hub 4338 that can contact the hearttissue 4352 and can serve as a stopping point for the anchor 4302 as itscrews into the heart tissue. The anchor hub 4338 can include an uppersurface that, in some embodiments, couples to a bushing 4353 (asdiscussed below). The anchor 4302 and the anchor hub 4338 may be joinedtogether through mechanical means, such as a frictional fit, by chemicalmeans, or through other means. The anchor hub 4338 can transfer forcesexerted on the retaining member 4304 (e.g., via the sutures 4308) intothe heart tissue 4252 via the anchor 4302. In this manner, the anchorhub 4338 works with the retaining member 4304 to dampen oscillatorymotion created by the heart's movements.

In some embodiments, the proximal surface of the anchor hub 4338contacts the suture lock 4306 (e.g., the nose portion of the suture lock4306) and the sutures 4308. The anchor hub 4338 (or at least itsproximal surface) may be formed of a material designed to augmentfrictional forces to secure the sutures 4308 located between the anchorhub 4338 and the suture lock 4306 or may be formed of a material thatreduces frictional forces to facilitate adjustment of the sutures 4308located between the anchor hub 4338 and the suture lock 4306. The anchorhub 4338 could be formed of PFA, silicone material, PTFE material, ePTFEmaterial, thermoplastics, and the like (or combinations thereof). Theanchor hub 4338, in some embodiments, is partially or fully formed ofmetal, stainless steel or titanium, or potentially a rigid plastic likePEEK, or other sufficiently rigid materials. The bushing, or proximalsurface of the anchor hub 4338 that interacts with the suture lock,could be made from PFA, silicone material, PTFE material, ePTFEmaterial, thermoplastics, and the like (or combinations thereof).

In some embodiments, a bushing 4353 is located adjacent the anchor hub4338 to cushion the suture lock 4306. This bushing may be formed of PFAor another polymer. The bushing provides a surface that contacts thesutures 4308 and, in combination with the nose portion of the suturelock 4306, helps to secure the sutures 4308. In some embodiments, thebushing facilitates suture adjustment due to the interactions of the PFAmaterial of the bushing and the ePTFE material of the sutures 4308.Bushing may also provide a surface that diminishes wear on the sutures,particularly if the anchor hub 4338 would otherwise present a roughersurface (e.g., due to the materials and/or surfaces of the anchor hub4338) against the sutures 4308. The bushing 4353, or the proximalsurface of the anchor hub 4338 that interacts with the suture lock,could be made from PFA, silicone material, PTFE material, ePTFEmaterial, thermoplastics, and the like.

In some embodiments, the diameter of the hub (e.g., hub 4338)corresponds to the minor or inner diameter of the support member 4354.Depending on how it is attached, the length of the hub 4338 issufficiently long to allow the support member 4354 to be attached to thehub 4338 and to have a driver engage with the hub 4338. The geometrywhere the retaining member 4304 is attached to the hub 4338 is smallerthan the minor diameter of the support member 4354. The outer diameterof the retaining member 4304 is smaller than the major diameter of thesupport member 4354 in some embodiments.

As shown in FIG. 52 , the anchor suture 4310 can pass through a channel4336 of the anchor hub 4338 and can be secured near the bottom surface4340 of the anchor hub 4338. In some embodiments, the channel 4336includes a bottleneck portion 4342 that secures the anchor suture 4310(e.g., by trapping a knot formed at the end of the anchor suture 4310below the bottleneck portion 4342). In other embodiments, the anchorsuture 4310 and the anchor hub 4338 be joined together throughmechanical means, such as a frictional fit, by chemical means, orthrough other similar means.

The suture lock 4306 may incorporate features of the suture locksdisclosed herein and/or PCT/US2017/069046 and PCT/US2019/021480. Thesuture lock 4306 can include a cylindrical outer surface thatcorresponds to the cylindrical chamber of the retaining member 4304 toprovide a frictional or interference fit. The suture lock 4306 caninclude a locking mechanism (e.g., an internal locking mechanism) thatselectively secures the anchor suture 4310 and the sutures 4308. Theillustrated suture lock 4306 includes a nose portion 4370 that presentsa rounded surface on which the sutures are pressed when tensioned. Inthis manner, the suture lock 4306 can avoid sharp edges that could fraythe sutures 4308. In some embodiments, the nose portion 4370 is formedof, e.g., PFA, or another material designed to reduce wear on thesutures.

The suture lock 4306 can travel down the anchor suture 4310 until itenters the cylindrical chamber of the retaining member 4304. Theretaining member 4304 can provide some radial resistance to the suturelock 4306 but can be radially compliant to receive the suture lock 4306.In some embodiments, the sutures 4308 can be adjusted, even when thesuture lock 4306 is bottomed out (i.e., passes down to the end of thesocket 4304, which could include pressing against the bushing 4353). Forexample, the sutures 4308 are most easily adjusted while the suture lock4306 is outside of the retaining member 4304. However, even after thesuture lock 4306 has entered the retaining member 4304, the sutures 4308can still be adjusted. When the suture lock 4306 bottoms out in someembodiments, the sutures 4308 are sandwiched between the PFA bushing4353 and the PFA nose 4370 of the suture lock 4306. At this stage, thesutures 4308 can still be adjusted in some embodiments, though withgreater resistance. For example, the material of the suture lock nose4370 and the bushing 4353 may reduce friction for easier adjustment. Inother embodiments, the bushing 4353 and the nose 4370 are designed tosecure the sutures and prevent further movement.

In some of the embodiments discussed above, the anchor 4302 ispre-assembled with the retaining member 4304. In other words, the anchor4302 and the retaining member 4304 are coupled together outside of thepatient. The suture lock 4306 is then coupled to the retaining member4304 (e.g., via an interference or frictional fit) inside of thepatient. In other embodiments, the retaining member 4304 and suture lock4306 are coupled together outside the patient. The retaining member 4304and the anchor 4302 are then coupled together (e.g., via an interferenceor frictional fit) inside of the patient.

In some embodiments, the retaining member 4304 is configured to expand.For example, in some embodiments the retaining member 4304 is formed ofa resilient material that expands as the suture lock 4306 is presseddown into the retaining member 4304 and will reseal around the suturelock 4306 to help secure it in place. In other embodiments, theretaining member 4304 has an expanded configuration and a retractedposition. The retaining member 4304 can be delivered in its expandedconfiguration and, once the suture lock 4306 is in place, the retainingmember 4304 collapses down to its retracted position to secure thesuture lock 4306 in place.

In some embodiments, and as shown in FIG. 53 , an anchor 4402 defines alongitudinal line 4403, and the retaining member 4404 or restrainingmember (e.g., socket) constrains movement of the suture lock 4406relative to the anchor 4402 in a direction orthogonal to thelongitudinal line 4403 defined by the anchor 4402. In some embodiments,the retaining member 4404 constrains movement of the suture lock 4406relative to the anchor 4402 in a plane orthogonal to the longitudinalline 4403. In some embodiments, the retaining member or restrainingmember (e.g., socket 4404) constrains movement of the suture lockrelative to the anchor along the longitudinal line 4403.

As also seen in FIG. 53 , the restraining member 4404 substantiallyaligns a longitudinal line 4403 defined by the anchor 4402 and/or alongitudinal line 4405 defined by the restraining member 4404 with alongitudinal line 4407 defined by the suture lock 4406. In someembodiments, the retaining member 4404 secures the suture lock 4406 in aco-axial relationship with the anchor 4402 and/or the retaining member4404. In some embodiments, the longitudinal lines defined by the anchor4402, retaining member 4404, and/or suture lock 4406 extends to aleaflet of the mitral valve.

In some embodiments, and as shown in FIG. 54 , the retaining member 4504constrains angular movement of a suture (suture 4511) relative to thesuture lock 4506. As discussed above with respect to FIGS. 49 and 50 ,in some embodiments the suture lock rotates in response to forces duringthe cardiac cycle, such that the angles formed by the portions of thesutures extending from the suture lock and towards the leaflets,relative to a longitudinal line defined by the suture lock, will varywidely. The location of the suture lock above the anchor and closer tothe leaflets also contributes to the angular movement. However, as shownin FIG. 54 , the retaining member 4504, by securing the suture lock 4506in a particular orientation, restrains angular movement of the suture4511. For example, in some embodiments, the angle 4520 formed betweenthe portion of a suture 4511 extending from the suture lock 4506 towardsthe leaflet and a longitudinal line 4522 of the suture lock 4506 is lessthan 45°. In some embodiments, angle 4520 can range from approximately−45° to +45°, which may also be understood as approximately 0° to 45° intwo opposite directions. This angle 4520 may be formed in any plane thatincludes that portion of the suture 4511 and the longitudinal line 4522of the suture lock.

While the suture 4511 will move during cardiac cycles, the retainingmember 4504 can constrains angular movement (changes in angle 4520) toless than 90°. In some embodiments, the angular change is less than 45°,while in other embodiments the angular change can be less thanapproximately 40°, 35°, 30°, 25°, 20°, 15°, 10°, 8° or even less thanapproximately 5°.

Method for measuring angular changes between ventricular anchor andsuture lock

The angular change between the anchor and suture lock can be determined,for example, with the following steps:

1. Fixture a ventricular anchor into one side of a tensile test machine.This can be done by simulating ventricular anatomy such as a siliconepad or by clamping into standard tensile test machine clamping jaws.

2. Fixture a prosthetic chordae into the other side of the tensile testmachine. This can be done by simulating leaflet anatomy such as asilicone pad or by clamping into standard tensile test machine clampingjaws.

3. Couple the ventricular anchor and the prosthetic chordae togetherusing a suture lock.

4. Load the system with the ventricular anchor, prosthetic chordae, andsuture lock in tension to a minimum of 2 N.

5. Measure the angle between the axis of the suture lock, or any linearfeature of the suture lock, and the axis of the ventricular anchor, orany linear feature of the ventricular anchor (Angle 1).

6. Unload the system with the ventricular anchor, prosthetic chordae,and suture lock to a load less than ON or a load equivalent to thehanging static weight of system on the load cell.

7. Measure the angle between the axis of the suture lock, or any linearfeature of the suture lock, and the axis of the ventricular anchor, orany linear feature of the ventricular anchor (Angle 2).

8. Calculate the difference between Angle 1 and Angle 2.

During installation of the prosthetic chord, the anchor and retainingmember can be delivered (e.g., via a catheter) and the anchor isimplanted into the ventricular tissue. An anchor suture extends from theanchor. Sutures (e.g., pledget sutures) are then coupled to one or moreof the mitral valve leaflets. A suture lock advances over the anchorsuture and the pledget sutures. In some embodiments, the physician canadjust the location of the suture lock relative to the pledget suturesso that length of the pledget sutures between the suture lock and theleaflet(s) can ensure that the prosthetic chord can operate adequately(e.g., to reduce and/or eliminate MR). For example, the physician canpull on a proximal portion of one of the sutures to decrease the amountof suture located between the suture lock and the mitral valve leaflet.

However, in certain embodiments the suture lock can be unrestrained. Asa result, adjustment of a suture (e.g., pulling on the suture) can movethe suture lock upwards, which impacts the tension on the portions ofthe sutures between the suture lock and the mitral valve. This issue canexacerbated when multiple sutures are used with the suture lock.Adjusting one of the sutures can raise the suture lock, undoing anyprior adjustments of another suture.

For example, the suture can be attached to a leaflet and passes througha suture lock, which functions as a moveable pulley for the suture.Specifically, when a physician pulls on the end portion of the suturelocated outside of the body, this will move the suture. However, pullingthe proximal end portion of the suture can move the suture lock upwards,such that the physician's movement of the suture external to the bodywill not have a one-to-one correspondence with the movement of thesuture between the suture lock and the leaflet.

This issue can be exacerbated when multiple sutures pass through asingle suture lock. For example, a physician can adjust a first sutureto the correct length. However, once the physician begins to adjust asecond suture, such movement will displace the suture lock, which couldnegatively impact the first suture and require the physician to readjustthe first suture. Of course, this could then negatively impact thesecond suture, leading to additional needed adjustments.

Additional complications arise when the physician cuts a suture afterengaging the suture lock. Prior to cutting the suture, the physicianmaintains tension on the suture, which maintains the suture lock in ahigher position. Cutting the suture (and/or disconnecting the suturelock from the catheter) will release this tension and the suture lockcan move downward, which can impact the effectiveness of the suture as aprosthetic-chord. That the physician should maintain tension on thesuture (e.g., on a first suture while adjusting a second suture) createsadditional complications. For example, any inadvertent movement of thecatheter (e.g., an accidental bump) could cause the suture lock to moveand change the length of the suture between the suture lock and thetissue (e.g., the leaflet).

Several of the embodiments discussed herein address these issues bysecuring the suture lock within the retaining member, thereby creating apivot point for the sutures that is relatively stationary relative tothe anchor. This can be particularly beneficial during adjustment of thesutures as the physician creates the prosthetic chord. Securing thesuture lock to the anchor (e.g., with the retaining member) cansubstantially eliminate that upward movement of the suture lock duringadjustment.

Furthermore, having a stationary pivot point can enable more directcorrelations between adjustments of a proximal portion of the suture(i.e., pulling on a portion of the suture located near the physician)and resulting adjustments in the distal portion of the suture (i.e., theportion of the suture between the suture lock and the mitral valve). Inparticular, many of these embodiments discussed herein enable precise,bi-directional adjustment of the sutures in which movement of theguiding device (e.g., a catheter) directly translates into length changeof the suture, e.g., between the leaflet and the suture lock. Forexample, if the guiding device is moved forward one millimeter, thesuture is also moved forward one millimeter. This is referred to as “oneto one motion.” As one of skill in the art will readily understand fromthis disclosure, several embodiments discussed herein can enable one toone motion or near one to one motion under various conditions. Inparticular, PCT/US2017/069046 and PCT/US2019/021480, which isincorporated by reference herein, disclosed mechanisms to make a suture“pushable,” including by placing a stiff tubular structure (i.e., acoil) over the suture. The stiffness provided by the coil allows thesuture to be pushed similar to a cardiac guide wire. In this regard, themotion of the modified suture follows the motion of the guiding device(e.g., the catheter or the coil) in a “one to one” manner.

Stated differently, securing the suture lock within the retaining membercan create fixed pivot point for the suture, such that the physician'smovement of the suture external to the body will have a one-to-onecorrespondence with the movement of the suture between the suture lockand the leaflet. As a skilled artisan will readily appreciate, in somesituations the one-to-one movement will be a near one-to-one movementdue to other changes (e.g., slight elongation of the sutures or minormovement of the suture lock within the socket), which are substantiallydifferent in nature and degree from the suture lock movements at issuein, e.g., unconstrained embodiments. For example, the movement ratiocould vary from 1:1 to approximately 1:0.95, 1:0.90, 1:0.85, 1:0.80,etc., down to 1:0.50.

Creating a fixed pivot point with the suture lock can create additionaladvantages. For example, when multiple sutures pass through the suturelock, each suture can be independently adjusted without substantiallyaffecting the other sutures. In particular, with the suture lock securedwithin the retaining member, a first suture can be adjusted to thecorrect length. The physician can then begin to adjust a second suturewithout disturbing the adjustment of the first suture, since the suturelock will not move with the second suture.

Furthermore, in some embodiments a portion of a first suture is locatedbetween the outer surface of the suture lock and the inner surface ofthe socket. The forces provided by those surfaces will retain thatportion of the first suture in place as the physician adjusts the secondsuture. This configuration provides additional advantages, as thephysician does not need to maintain external tension on the firstsuture. Reducing or eliminating tension on the suture can reduce anyelongation or other detrimental effects on the sutures.

In addition, the first suture can be cut without changing the locationof the suture lock and without changing the length of the suture betweenthe suture lock and the tissue. As a skilled artisan will appreciate,there may be some incremental movement (e.g., less than 5/1000th of aninch or less than 5/100th of an inch), which could be deemed less than asubstantial change in location in this context.

Furthermore, in some embodiments the suture lock serves as a fixed pivotpoint located close to a target area of tissue (e.g., near the apex ofthe heart), which can increase the ease of installation.

In some embodiments multiple sutures are coupled to tissue(s) (e.g., oneor more leaflets) and pass through the suture lock. Each suture has alength extending between the suture lock and the tissue(s). When thesuture lock is placed into the retaining member, the sutures are held inplace. Should a first suture need to be adjusted (e.g., decrease thelength of the first suture between the suture lock and the tissue), thesuture lock can be removed from the retaining member and the physiciancan pull on the first suture to reduce its length. However, the locationof the suture lock remains relatively static during this adjustment(e.g., the suture lock moves no more than 1 mm.) As a result, thephysician does not need to further adjust or readjust the other sutures.In some embodiments, the sutures can be adjusted while the suture lockis within the retaining member. The retaining member secures the suturelock, further reducing or eliminating movement of the suture lock duringadjustment of a suture. For example, movement of the suture lock can beless than or equal to approximately 0.5 mm.

In some embodiments, the suture lock engaged in the retaining member isloose enough that the force of the leaflet on the suture (e.g., an ePTFEchord) is sufficient to pull the suture through the interface betweenthe suture lock and the retaining member, around the nose of the suturelock, through the open clamping mechanism of the suture lock and back tothe stiffened pushable portion of the suture assembly. Operable forcesfor this situation can vary from 0 N to approximately 2 N. In someembodiments, the forces may range from 0.15 N to 1.50 N.

In some embodiments, the physician pulls on the external portions of asuture to decrease the length of that suture between the suture lock andthe leaflet. Should the physician wish to increase the length of thesuture between the suture lock and the leaflet, the physician canrelease tension on the external portions of the suture, and the movementof the leaflet during the heart's natural cardiac cycle will pull on thesuture. In some embodiments, the suture lock is placed into a firstportion of the retaining member, where the forces acting on the suturesare small enough that the physician and the leaflet can effect changesin the length of the sutures between the suture lock and the leaflet,e.g., forces between 0 N to 2 N. At the same time, the securing forcesprovided by the retaining member prevent the suture lock from movingduring these adjustments or restricts movement of the suture lock toaround 0.5 mm.

In some embodiments, once the lengths of the sutures between the suturelock and the corresponding tissues are correct (e.g., MR is clinicallyreduced or eliminated), the suture lock is pressed into a second portionof the retaining member, where the retaining member can apply greatersecuring forces to the suture lock and the sutures. As a result, theforces provided by the leaflet will not cause the suture to move withinthe suture lock (or to move only by a small amount, e.g., around 0.5mm), so that the length of the sutures between the suture lock and thetissues remains constant (or moves only by the amount of stretchprovided by the sutures, e.g., approximately 10%). At this point, thephysician can take a measured analysis of the placement and tensionprovided by the prosthetic chords. If satisfactory, the physician canengage the suture lock to clamp down on the sutures. In thisconfiguration, the prosthetic chords can operate for at least 400million cycles, i.e., about 10 years, or even at 800 million cycles orabout 20 years. In certain example embodiments, the prosthetic chordscan operate for at least 400 million cycles, i.e., 10 years, or even at800 million cycles or 20 years.

In some embodiments, the sutures are permanently secured using only therestraining forces provided by the retaining member, either alone or incombination with the external surface of the suture lock. For example,the suture lock may lack any internal clamping or restrainingmechanisms, instead providing an outer surface that, along with theinner surface of the retaining member, secures the sutures againstfurther movement from the forces originating from the heart's naturalcycles.

In some embodiments, the retaining member enables the suture lock towork with sutures of different sizes. For example, sutures of a largersize and/or thickness may be secured once the suture lock is insertedinto a first portion of the retaining member. Sutures of a smaller sizecan also be secured, e.g., by pressing the suture lock deeper into theretaining member.

Embodiments of the present disclosure can provide further advantagesthat facilitate easy adjustment of the suture. For example, friction cancreate difficulties in adjusting the sutures, as well as the life andefficacy of the sutures. Some embodiments address this issue by using asuture lock having a tapered nose. For example, and as shown in FIG. 52, the distal end of the suture lock 4306 includes a tapered nose 4370.The outer surface of the suture lock 4306 has a cylindrical shape, andthe outer surface of the nose portion 4370 likewise has a cylindricalshape whose radius decreases towards the distal end of the nose 4370.

The front surface of the nose portion 4370 presents an inner aperturesurrounded by a ring of the tapered nose. In some embodiments, thediameter of the inner aperture can range from 1 mm to 3 mm. Thethickness of the ring can range from 0.5 mm to 2.0 mm.

The tapered nose portion 4370 can facilitate insertion of the suturelock 4306 into the retaining member 4304. In some embodiments, the noseportion 4370 tapers more steeply while in other embodiments the noseportion 4370 tapers less steeply. In addition, or alternatively, theretaining member 4304 may include a proximal portion whose profiletapers outward to guide the suture lock 4306 into interior portions ofthe retaining member 4304. For example, the proximal end of theretaining member 4304 may have a larger radius than a middle portion ofthe retaining member 4304. As discussed above, an anchor suture 4310 canalso be used to guide the suture lock 4306 down into the retainingmember 4304.

As shown in FIG. 52 , the interior surface of the nose portion 4370 caninclude a proximal portion whose thickness increases along alongitudinal line from the front portion to a middle portion. After thatmiddle portion, the thickness of the nose portion decreases towards adistal portion. The proximal end of the nose portion may be configuredto snap fit onto the suture lock body in some embodiments.

To facilitate bi-directional adjustment, certain embodiments reduce thefrictional forces on the sutures via the suture lock and the retainingmember. For example, the profile of the nose provides a rounded surfacethat facilitates movement of the suture around the nose without creatingsharp edges that wear down the suture. In addition, the composition ofthe nose can include, e.g., PFA or other materials that further reducefriction between sutures and the nose.

The nose portion can be configured to accommodate multiple suturessimultaneously. At the same time, the tapered profile enables easieraccess into the retaining member. To take advantage of both of thesefeatures, the size of the aperture in the nose portion can correspond tothe number of sutures to be used. For example, the diameter of the noseaperture may be 1 mm when two sutures are used, and the diameter of thenose aperture may be 2 mm when four sutures are used. Generallyspeaking, the ratio of diameter to number of sutures may beapproximately 0.5 mm per suture. In some embodiments, different noseportions (e.g., nose portions with apertures of different sizes) may beinterchangeably used with a single suture lock body. In otherembodiments, the size of the suture lock (e.g., the diameter of thesuture lock) is larger or smaller to accommodate different numbers ofsutures.

In some embodiments, the retaining member is formed of an ePTFE materialin which the fibrillar orientation of the film microstructure isoriented in a direction substantially parallel the longitudinal axis ofthe retaining member. In this manner, any longitudinal motion of thesuture (e.g., an ePTFE suture) will be in line with the fibrillarorientation to further reduce friction and wear on the sutures. Forexample, in some embodiment, the retaining member (in whole or at leastthe interior surface) is formed of a substantially monolithic ePTFEcovering having a node and fibril microstructure in which the nodes areoriented generally perpendicular to the longitudinal axis of theretaining member and the fibrils are oriented generally parallel to thelongitudinal axis of the retaining member.

As discussed above, the retaining member engages the sutures and/or thesuture lock. In some embodiments it is necessary to disengage the suturelock from the retaining member to allow slack into the sutures. Thissimplifies maintaining tension in one suture relative to another becauseit eliminates the length changes created through the catheter. In theseembodiments the suture lock can be disengaged from the interference fitwith the retaining member to add slack to the sutures. In other words,in some embodiments multiple sutures pass through the suture lock, whichis inserted into the retaining member. As a result, the sutures are heldin place between the outer surface of the suture lock and the interiorsurface of the retaining member. Should the physician need to adjust oneof the sutures, the suture lock can be removed from the retainingmember. At this stage, the suture at issue can be adjusted withoutsignificant upward movement of the suture lock. Accordingly, adjustmentof that suture does not significantly alter the tension in the othersutures.

In some embodiments, the retaining member serves as a prostheticpapillary muscle as part of the prosthetic chord. The materials selectedfor, e.g., the retaining member and the suture (as well as the anchorand/or suture lock) can be selected to promote tissue encapsulation,tissue ingrowth, and/or particular biological reactions.

FIG. 55 illustrates another embodiment of a transcatheter mitral chordalrepair system 4600. This system 4600 includes features similar to thoseshown in FIGS. 51 and 52 . However, in this embodiment the retainingmember 4604 does not include a support member. Instead, the anchor 4602extends around the anchor hub 4638 at terminates at the lower surface ofthe retaining member 4604. A mechanical bond or joint 4601 secures theretaining member 4604 to the anchor hub 4638. The anchor 4602 and theanchor hub 4638 can be joined together in a manner as discussed above.In FIG. 55 , the walls of the retaining member 4604 can be 25% to 100%thicker than the walls of the socket in FIGS. 51 and 52 . Thicker wallscan provide axial support to prevent buckling as the suture lock 4606enters the retaining member 4604, while still being compliant enough topermit passage. A mechanical bond or joint secures the anchor hub 4638to the retaining member 4604, which extends over the anchor hub 4638.

Some embodiments involve a method for transcatheter mitral chordalrepair using a transcatheter mitral chordal repair system. During thisprocess, the anchor and anchor socket are delivered together, e.g., viaa delivery catheter. FIGS. 56-58 illustrate a method of deploying ananchor 4702, socket 4704, and suture lock 4706. In FIG. 56 , the anchor4702 is located within the socket 4704. In this configuration, bothanchor 4702 and socket 4704 can be passed through a catheter and intothe left ventricle (e.g., via the left atrium). In some embodiments, theanchor 4702 is fully retracted within the socket 4704 to prevent theanchor 4702 from contacting or piercing the catheter or other tissue.Once the socket 4704 is located against the ventricular wall, the anchor4702 is advanced out of the socket 4704 and into the tissue. A socketattachment device 4755 captures the coil threads as the anchor 4702emerges from the socket 4704, until the socket attachment device 4755ultimately contacts the anchor hub 4738 to lock the anchor 4702 inplace. In some embodiments, the socket attachment device 4755 is asuture with a loop or a series of loops through which the coil passes.In other embodiments, the socket attachment device 4755 is an extensionof the socket material at the distal end of the socket 4704, thisextension having a hole or series of holes through which the coilpasses. In both these examples, extrusion of the coil through the holeor loop advances the coil until the socket attachment device 4755 issecured against the anchor hub 4738.

FIG. 57 illustrates the anchor 4702 and socket 4704 once the anchor 4702is deployed into the ventricular tissue. A socket attachment device 4755secures the anchor hub 4738 (and thus the anchor 4702) in place relativeto the socket 4704. The suture lock 4706 is then advanced along theanchor suture 4710 into the socket 4704 until it contacts the bushing4753, as shown in FIG. 58 . Once the sutures 4708 are correctlytensioned, the suture lock 4706 can be activated and locks the sutures4708 and the anchor suture 4710 in place. The suture lock 4706 iscoaxially aligned with the anchor 4702, in parallel with the sutures4708 that are pinned between the outer surface of the suture lock 4706and the inner surface of the socket 4704. The sutures 4708 are alsopinned between the curved nose of the suture lock 4706 and the bushing4753.

FIGS. 59 and 60 illustrate another embodiment of a transcatheter mitralchordal repair system 4800. This system can include features similar tothose shown in FIGS. 51 and 52 . In this embodiment, an anchor pledget4860 is incorporated into the anchor suture 4810. As the suture lock4806 is advanced into the socket 4804, the anchor pledget 4860 collapsesto create a bushing in between the anchor hub 4838 and suture lock 4806.The suture lock 4806 can selectively engage the sutures 4808 coupled toleaflets and remaining portions of the anchor suture 4810.

FIG. 61 illustrates a socket formed of densified ePTFE 4850. In someembodiments the socket is formed of ePTFE. The socket can be formed byfolding a tube back on itself, creating two layers. This reinforces thesocket to resist axial compression and folding as the suture lock entersthe socket. In some embodiments, the retaining member is made from athick-wall graft material. To increase the axial stiffness, the thickwall graft material can be densified. An example of this is shown inFIG. 61 , depicting a graft material that has been rolled to obtain theproper thickness and density. Furthermore, the resulting two-layerconstruct increases densified pliability.

FIG. 62 illustrates a “rolled” end 4852 of the PTFE socket. In someembodiments the socket is formed of ePTFE. The marker band 4854 isplaced on the exterior surface of the tube before it is rolled, locatedso that the band is placed between the two rolled layers at the top ofthe socket. This band can be a radiopaque band. In some embodiments, theretaining member includes an end portion whose radial stiffness isdifferent than other portions. For example, the proximal portion of aretaining member can be formed with an increased radial stiffness. Insome embodiments, a marker band is placed between layers of the graftmaterial as it is rolled to form the retaining member, as shown in FIG.62 . This marker band increases the radial stiffness and makes thisportion of the retaining member radiopaque. In some embodiments, themarker band is retained between the two layers of PTFE or ePTFE anddensified into the PTFE or ePTFE structure.

FIGS. 63 and 64 illustrate a densified PTFE socket 5004 designed tointerface with an anchor hub 5016. In some embodiments the socket 5004is formed of ePTFE. The densified PTFE or ePTFE socket 5004 includes alower extension 5070 designed to fit around a corresponding groove 5072in the anchor hub 5016. This secures the socket 5004 to the hub 5072. Aradiopaque band 5074 is located near the top of the socket 5004. Thedensified PTFE or ePTFE can be used to keep retention of the anchor. Asshown in FIG. 63 , by pressing the PTFE or ePTFE into a retention ringon the anchor, it will be held in place. FIG. 64 illustrates anexemplary retaining member in which a marking band has been incorporatedinto a proximal portion while a distal portion include a densifiedportion designed to retain an anchor (not shown in FIG. 64 ).

FIGS. 65A and 65B illustrate a socket formed by inverting a vasculargraft tube, creating an outside wall and an inside wall. This creates asocket from materials that are biocompatible. This material can be thesame as the suture material, thereby minimizing or lessening wear of thesutures where they exist the socket. The direction of the fibrils of thesocket surfaces can be oriented to match the direction of the fibrils ofthe suture to further minimize wear.

The various prosthetic chordae tendinae deployment systems discussedabove can be used in many different medical applications. Theseembodiments can reduce or eliminate movement of the sutures relative tothe suture lock as well as movement of the suture lock relative to theanchor. For example, in some embodiments an anchor is delivered intoheart tissue, e.g., near the apex of the left ventricle or near apapillary muscle. As discussed above, the anchor can be deliveredthrough a trans-septal catheter advanced into the left atrium andthrough the mitral valve. The anchor is a helical anchor and is coupledto a retaining member. In some embodiments, the anchor is initiallydelivered within the retaining member and is advanced out of theretaining member and into the heart tissue. An anchor suture is attachedto the anchor (e.g., via an anchor hub). A leaflet anchor (e.g.,pledget) is then delivered and attached to a leaflet of the mitralvalve. In some embodiments, the pledget is located on the ventricle sideof the leaflet with a pledget suture extending from the atrium side ofthe leaflet. In other embodiments, the pledget is located on the atriumside of the leaflet and the pledget suture extends from the ventricularside of the leaflet. Multiple pledgets and sutures may be placed in oneor more leaflets.

To affect the prosthetic chordae tendinae, in certain embodiments, asuture lock can be advanced over the anchor suture and the sutures.Specifically, the proximal ends of the sutures enter through an aperturein the suture lock and pass through the suture lock. The suture lock isadvanced towards the retaining member, guided by the suture anchor.Because the suture lock is radiopaque, and because the retaining membercan include a radiopaque band near its proximal surface, the physiciancan use imaging technology to confirm the location of the suture lockrelative to the retaining member. Furthermore, the use of a radiopaqueband in the retaining member enables the physician to confirm once thesuture lock has been fully inserted into the retaining member.

In certain embodiments, once the suture lock reaches the retainingmember, the physician can adjust the length of the sutures between thesuture lock and the leaflet to effect each new prosthetic chordaetendinea. In some embodiments, some or all of this adjustment is madewith the suture lock at or in the retaining member. In certainembodiments, any movement of the sutures can result in one-to-onemovement or near one-to-one movement of the suture distal of the suturelock, as the suture lock is maintained in a relatively constant positionat the retaining member. For example, the ratio of proximal suturemovement to distal suture movement can be from 0.5 to 1.0.

In some embodiments, this adjustment is made with the suture lock justoutside of the retaining member, with the physician holding the suturelock in place and holding the sutures in tension. In other embodiments,this adjustment is made with the suture lock in the retaining member(either in a proximal portion of the retaining member or into a distalportion of the retaining member adjacent the anchor hub). In theseembodiments, the retaining member holds the suture lock in place butenables the sutures to slide through the suture lock. The physician doesnot need to hold the suture lock in place.

Furthermore, in some embodiments the restraining force of the retainingmember can be sufficient to hold the sutures in place against the forcesexerted by the leaflet, and yet permit the sutures to slide in responseto pulling forces from the physician. In these embodiments, thephysician does not need to hold the suture lock in place and also doesnot need to hold each suture in tension. Instead, the retaining membermaintains the tension of the distal portion of the pledget suture (i.e.,the portion of the pledget suture distal of the retaining member andextending to the leaflet). This allows the physician to individuallyadjust each pledget suture, and any inadvertent movement of the catheter(e.g., accidental bumping) will not affect the sutures. Of course, theadjustments by the physician in this situation are in one direction(i.e., shortening the length of suture between the suture lock and thepledget). Should the physician need to increase the length of the suturebetween the suture lock and the pledget, the physical can remove thesuture lock from the suture so that movement by the leaflets will againpull the sutures through the suture lock.

Once the sutures are appropriately tightened, the physician can lock thesutures in place using the suture lock, e.g., using the techniquesdescribed herein and/or in PCT/US2017/069046 and PCT/US2019/021480. Inother embodiments, the retaining member locks the sutures in placewithout the need for an additional locking mechanism within the suturelock. The physician can then cut the excess suture (e.g., the suturelocated proximally of the retaining member). Because the sutures are notin tension proximal of the retaining member, cutting these sutures willnot cause significant movement of the suture lock and/or the sutureslocated between the suture lock and the leaflets.

In other embodiments, the retaining member and the suture lock areintegrated and are delivered as a unit. In some embodiments, that unitincludes the anchor or is coupled to the anchor during the deliveryprocess. The physician can adjust the length of the sutures extendingbetween the suture lock and the leaflets and can using the suture lockto permanently lock the sutures in place.

The resulting prosthetic chordae tendinae in these embodiments can bemore durable than prior prosthetic chordae tendinae. First, movement ofthe sutures relative to the suture lock is reduced or eliminated,reducing the wear of the sutures. Second, movement of the suture lockrelative to the anchor is reduced or eliminated, further reducing thewear of the sutures. The orientation of the sutures relative to thesuture lock also reduces suture wear. Additional features discussedabove (including, e.g., the nose portion of the suture lock) increasesthe lifetime of the prosthetic chordae tendinae.

FIG. 66 illustrates an anchor, retaining member, and suture lockaccording to aspects of the present disclosure. FIG. 67 illustrates anorientation of a prosthetic chord, according to aspects of the presentdisclosure.

Suture Lock Boot

In certain aspects described herein, once the tension and length of theneo chordae implant is optimized, the suture lock can locked to fix thelength of the sutures such that the sutures no longer move with respectto the suture lock.

In further aspects of the disclosure, after tensioning of the sutures bythe physician to correct or minimize the mitral valve defect, thesutures can be clamped or pinned or otherwise engaged and locked in thesuture lock so that the applied length adjustment and tension of thesutures is retained. With this step and resulting lock engagement, themitral defect can be corrected or minimized and remains correctedthroughout the functional lifetime of the neo chordae (i.e., theprosthetic chord). In order to advance the suture lock through thedelivery catheter and to clamp or pin the sutures within the suturelock, the suture lock can be coupled to a lock driver mechanism thatallows the physician to provide the necessary force to clamp orotherwise lock the sutures within the suture lock, i.e., a lock driver,such as lock screw driver in one alternative embodiment, for example, astored energy mechanism, or the like, depending on the tighteningrequirements of the suture lock.

In some aspects, the suture lock may further be coupled to a bootlocated on or with the lock driver, wherein the boot comprises aretaining mechanism configured to reversibly retain the suture lock tothe boot to enhance engaging of the lock driver. According to someembodiments and as shown, for example, in FIG. 68 , the system comprisesdelivery catheter 6905, suture lock 6935 and boot 6915. Also shown inFIG. 68 , suture lock 6935 includes screw 6925 which engages with lockdriver 6910, wherein the lock driver can be rotated in order to advanceor retract ramp (or push wedge) 6930, thereby clamping sutures 6945against an opposing internal surface of the suture lock 6940. Suturelock 6935 is coupled to boot 6915. Lock driver 6910 (shown by dottedlines) is engaged with the screw head of screw 6925. The insertion oflock driver 6910 coaxially through boot 6915 can force suture lockretaining member 6920 (two suture lock retaining members 6920 are shownin FIG. 68 , on opposite sides of boot 6915 from each other) to protrudefrom the outer surface of boot 6915. The suture lock retaining member6920 can provide a frictional fit (not shown) to the suture lock 6935 orcan engage one or more indentations (shown in dotted perspective view)in the suture lock 6935. In an alternative embodiment, a frictional fitbetween the lock driver and the boot alone may be used, without therequirement for suture lock retaining member(s) or indentation(s).Provided that the lock driver 6910 is positioned at a position that isdistal to the suture lock retaining member 6920, then the suture lockretaining member 6920 of the boot 6915 will couple with the suture lock6935 to restrict or eliminate movement of the suture lock 6935 relativeto the boot 6915. Once the physician has tensioned the sutures tocorrect the movement of the mitral valve, the physician can then rotatethe lock driver 6910 to clamp or pin the sutures within the suture lock6935. It would be apparent to one of skill in the art than alternativesuture lock clamping or locking configurations are within the scope ofthe present disclosure, such as either pushing or pulling componentstogether to engage the locking of the suture lock.

Once the sutures have been clamped within the suture lock, the physiciancan use any known visualization technique in order to confirm that themitral valve defect has been corrected or minimized. If, for example,further adjustments need to be made, the lock driver 6910 can be rotatedin order to lessen the force on the sutures 6945 and adjust the tensionas needed and repeat the procedure to clamp the sutures. Uponconfirmation that the mitral valve defect has been corrected orminimized, lock driver 6910 can be retracted, thereby disengaging fromthe screw head of screw 6925.

FIGS. 69 and 70 depict removing the lock driver 6910 and the boot 6915from the suture lock 6935. As lock driver 6910 is retracted from thesuture lock and past the suture lock retaining member, the suture lockretaining members retracts into the boot, thereby disengaging the boot6915 from the suture lock. With the suture lock retaining membersretracted, the boot 6915 can also disengage from the suture lock. Oncethe boot 6915 disengages the suture lock retaining member 6920 (notshown) from the suture lock 6935, the physician can then remove the lockdriver 6910 and the boot 6915 from the catheter.

In some embodiments, the anchor may further comprise a retaining memberconfigured to couple with the suture lock so that the suture lockmaintains a positional relationship with the anchor. In theseembodiments, the physician can apply pressure on the lock driver and theboot in order to insert the suture lock into the retaining member. Oncethe suture lock has been inserted into the retaining member and thesutures have been properly tensioned, then the sutures can be clamped inthe suture lock, and the lock driver and the boot can be retracted fromthe suture lock and from the catheter as was discussed above.

The suture lock can further comprise alternative mechanisms configuredto actuate the suture retaining mechanism. In some embodiments, thesuture retaining mechanism can be a screw wherein the rotation of thescrew can reversibly apply or remove pressure on the sutures. FIGS.68-70 show embodiments wherein the suture retaining mechanism comprisesa screw 6925, one or more ramps 6930 and a surface of the suture lock6940. The ramp and/or the opposing surface of the suture lock cancomprise a plurality of notches, each having a height that is advancedto clamp the sutures by the rotation of a screw. The height of eachnotch may increase or decrease from an innermost notch to an outermostnotch. Other suture retaining mechanism such as, for example, a springor other stored energy mechanism may be used to provide the force thatclamps the sutures within the suture lock. The spring can be activated,for example, in any known way whereby stored energy of the spring couldbe released during the removal of the boot from the suture lock.

In certain arrangements, a suture can include a thread, cable, wire,filament, strand, line, yarn, gut, or similar structure, whether naturaland/or synthetic, in monofilament, composite filament, or multifilamentform (whether braided, woven, twisted, or otherwise held together).

Although this disclosure describes certain embodiments and examples,many aspects of the above-described systems and methods may be combineddifferently and/or modified to form still further embodiments oracceptable examples. All such modifications and variations are intendedto be included herein within the scope of this disclosure. Indeed, awide variety of designs and approaches are possible and are within thescope of this disclosure.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of a subcombination.

The disclosure herein of any particular feature, aspect, method,property, characteristic, quality, attribute, element, or the like inconnection with various embodiments can be used in all other embodimentsset forth herein. Also, any methods described herein may be practicedusing any device suitable for performing the recited steps.

Moreover, while components and operations may be depicted in thedrawings or described in the specification in a particular arrangementor order, such components and operations need not be arranged andperformed in the particular arrangement and order shown, nor insequential order, nor include all of the components and operations, toachieve desirable results. Other components and operations that are notdepicted or described can be incorporated in the embodiments andexamples. For example, one or more additional operations can beperformed before, after, simultaneously, or between any of the describedoperations. Further, the operations may be rearranged or reordered inother implementations. Also, the separation of various system componentsin the implementations described above should not be understood asrequiring such separation in all implementations, and it should beunderstood that the described components and systems can generally beintegrated together in a single product or packaged into multipleproducts.

In summary, various illustrative embodiments and examples are describedherein. Although the systems and methods have been disclosed in thecontext of those embodiments and examples, this disclosure extendsbeyond the specifically disclosed embodiments to other alternativeembodiments and/or other uses of the embodiments, as well as to certainmodifications and equivalents thereof. This disclosure expresslycontemplates that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another.Accordingly, the scope of this disclosure should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow as well astheir full scope of equivalents.

1. A tissue anchor, comprising: a hub; a suture extending proximallyfrom the hub; a helical anchor extending distally from the hub; and asecondary anchor axially moveable in a distal direction from a firstconfiguration to a second, deployed configuration to engage tissue andinhibit unscrewing of the helical anchor.
 2. The tissue anchor as inclaim 1, wherein the secondary anchor comprises a tine that is carriedby a support and extends between a proximal end and a sharpened distalend.
 3. (canceled)
 4. The tissue anchor as in claim 2, wherein thesupport comprises an annular structure.
 5. The tissue anchor as in claim2, wherein the support can receive a tubular structure of a deploymentsystem for advancing the support distally with respect to the helicalanchor.
 6. The tissue anchor as in claim 2, wherein the hub includes atine guide for axially moveably receiving the tine.
 7. The tissue anchoras in claim 6, wherein the tine guide includes a deflection surface fordeflecting the tine into a launch angle that inclines radially outwardlyin the distal direction.
 8. The tissue anchor as in claim 7, wherein thelaunch angle is within a range of 30 to 45 degrees.
 9. The tissue anchoras in claim 1, wherein the hub includes an aperture for axially moveablyreceiving the secondary anchor.
 10. The tissue anchor as in claim 1,further comprising a core wire attached to the hub and extendingconcentrically through the helical anchor, and a suture anchor guideextending proximally from the hub.
 11. (canceled)
 12. The tissue anchoras in claim 10, wherein in a second, deployed configuration thesecondary anchor extends through the suture anchor guide.
 13. The tissueanchor as in claim 12, wherein the secondary anchor extends through anaperture in the suture anchor guide.
 14. The tissue anchor as in claim13, wherein as the secondary anchor moves to the second, deployedconfiguration, the secondary anchor is operable to pierce the sutureanchor guide.
 15. The tissue anchor as in claim 1, further comprising aradiopaque marker carried by the secondary anchor.
 16. The tissue anchoras in claim 1, further comprising a core wire attached to the hub andextending concentrically through the helical anchor, a radiopaque markeraxially movably carried by the core wire, and a spring carried by thecore wire.
 17. (canceled)
 18. (canceled)
 19. The tissue anchor as inclaim 14, wherein the core wire extends distally beyond the helicalanchor.
 20. The tissue anchor as in claim 16, further comprising adistal stop on the core wire operable to limit distal travel of theradiopaque marker.
 21. The tissue anchor as in claim 1, furthercomprising a tissue piercing point on a distal end of the helicalanchor, and a barb on the helical anchor, proximal to the point andconfigured to resist rotation of the helical anchor out of engagementwith tissue.
 22. The tissue anchor of claim 1, wherein the secondaryanchor is operable to increase an anchor torque resistance of the tissueanchor by a factor between 2 to 5 as compared to an anchor torqueresistance of the tissue anchor without the secondary anchor.
 23. Thetissue anchor of claim 1, wherein an anchor torque resistance of thehelical anchor with the secondary anchor is between 2 N/cm to 5 N/cm.24. The tissue anchor of claim 1, wherein the secondary anchor increasesan anchor torque resistance of the helical anchor by at least a factorof 2 as compared to an anchor torque resistance of the tissue anchorwithout the secondary anchor. 25-47. (canceled)